Bistos BT-500 User manual

Keep this manual for future reference
P/N : 500-ENG-OPM-EUR-R07
BT-500
BT-500
Infant Incubator

BT-500 Operation Manual 1
P/N : 500-ENG-OPM-EUR-R07
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 R07
Mar,2018
Copyright © Bistos Co., Ltd. 2018. 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
1. SAFETY............................................................................................4
1.1 Instructions for the Safe Operation and Use of the BT-500................................4
1.2 Warnings.............................................................................................................5
1.3 Shockh azards...................................................................................................12
1.4 General precaution on environment..................................................................13
1.5 Definitions and symbols ...................................................................................15
2. INTRODUCTION..........................................................................16
2.1 General..............................................................................................................16
2.2 Breif Device Description ..................................................................................16
2.3 Intended Use.....................................................................................................16
2.4 Operating Principles..........................................................................................16
2.5 Essential performance.......................................................................................17
2.6 Options and Accessories ...................................................................................17
2.7 Appearance of BT-500......................................................................................19
2.7.1 BT-500 Front view..................................................................................................19
2.7.2 BT-500 Front view Detail .......................................................................................20
2.7.3 BT-500 Rear view...................................................................................................20
2.7.4 BT-500 Side view....................................................................................................21
2.8 Description of each part....................................................................................22
2.8.1 Control shell............................................................................................................22
2.8.2 Hood .......................................................................................................................23
2.8.3 Mattress tray ...........................................................................................................23
2.8.4 Stand .......................................................................................................................24
3. INSTALLATION & CONNECTION...........................................25
3.1 IV pole Assembly..............................................................................................26
3.1.1 IV Extenal Monitor................................................................................................27
3.1.2 IV plate ..................................................................................................................28
3.1.3 IV ringer ploe.........................................................................................................29
3.2 Air Filter Assembly...........................................................................................30
3.3 Connection of Power and Cable........................................................................31
3.3.1 Power Connection..................................................................................................31
3.3.2 Cable Connection...................................................................................................31
3.3.3 Sensor Module Connection....................................................................................32
3.4 Placement Infant ...............................................................................................32
3.5 Movement and Innstallation .............................................................................32
4. OPERATION..................................................................................34
4.1 System Start-up.................................................................................................34
4.2 LED...................................................................................................................36
4.3 Key and knob operation....................................................................................37
4.3.1 Key.........................................................................................................................37
4.3.2 Knob ......................................................................................................................37
4.4 Displays ............................................................................................................38
4.5 Temperature Measurement and Control............................................................40

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4.6 Humidity Measurement and Control.................................................................42
4.7 O2 Measurement...............................................................................................43
4.8 Weighting Scale Measurement..........................................................................44
4.9 SpO2 and PR(pulse rate) Measurement............................................................44
4.10 Menu functions ...............................................................................................44
4.11 Pulse Oximeter................................................................................................50
4.12 External Monitor.............................................................................................53
4.13 Shut down.......................................................................................................55
4.14 Calibration of O2 module ...............................................................................56
5.ALARMS.........................................................................................58
5.1 System alarms...................................................................................................58
5.2 Temperature alarms...........................................................................................59
5.3 Humidity alarms ...............................................................................................61
5.4 Oxygen alarms..................................................................................................61
5.5 Weighting Scale alarms.....................................................................................61
5.6 Alarm self-test...................................................................................................62
6. CLEANING & MAINTENANCE.................................................63
6.1 General cleaning method and precuations ........................................................63
6.2 Hood .................................................................................................................64
6.3 Shell, Sensor module, Scale module, Basket....................................................64
6.4 Water tankt........................................................................................................64
6.5 Skin temperature sensors and SpO2 sensors.....................................................65
6.6 Drain of residual water......................................................................................65
6.7 Regular Inspection............................................................................................66
6.8 Battery Replacement and Disposal ...................................................................67
6.9 Disposal of the BT-500.....................................................................................67
7. SPECIFICATION...........................................................................68
8. TROUBLESHOOTING.................................................................72
8.1 General Checking .............................................................................................72
8.2 Alarm Message Checking .................................................................................72
9. MANUFACTURER’S DECLARATION .....................................75
9.1 Electromagnetic emissions................................................................................75
9.2 Recommended separation distances between portable and mobile
RF communications equipment and the EUT...................................................75
9.3 Electromagnetic immunity................................................................................76
WARRANTY ......................................................................................78

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Section 1
Safety
1.1 Instructions for the Safe Operation and Use of the
BT-500 Incubator
Examine the incubator and any accessories periodically to ensure that the
cables, line cords and instruments do not have visible evidence of damage that
may affect patient safety or performance. The recommended inspection
interval is once per week or less. Do not use the incubator if there is any
visible sign of damage.
Only the AC line cord supplied with the BT-500 is approved for use with the
Unit.
Do not attempt to service the BT-500 incubator. Only qualified service
personnel by Bistos Co., Ltd. should attempt any needed internal servicing.
The BT-500 is not specified or intended for operation during the use of
defibrillators or during defibrillator discharge.
The BT-500 is not specified or intended for operation in the presence of
electrosurgical equipment.
The BT-500 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.
Perform periodic safety testing to insure proper patient safety. This should
include leakage current measurement and insulation testing. The recommended
testing interval is once per year.
Do not operate the BT-500 incubator if it fails to pass the power on self-test
procedure.
WARNING
Be informed that it may cause serious injury or death to
the patient, property damage, material losses against the
“WARNING” sign.
CAUTION
Be informed that it may cause no harm in life but lead to
injury against the “CAUTION” sign.
SHOCK HAZARD
Be informed that it may cause serious electrical shock to
the patient or operator, property damage, material losses
against the “SHOCK HAZARD” sign.

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1.2 Warnings
WARNING

Thoroughly read and understand the manual prior to use of the
incubator. Failure to do so could result in personal injury or
equipment damage.)
Incubator misuse may result in harm to an infant. Only properly
trained personnel should use the incubator as directed by an
appropriately qualified attending physician aware of currently
known risks and benefits.
Use of accessories other than those listed and approved for use in
this product as original or replacement items may result in
increased emissions or decreased immunity.
The total electrical current leakage of all items powered through
the incubator, including devices on the outlet strip, must be less
than 300uAfor 120VAC/ 100VAC systems and less than 500uA
for 230VAC systems. Otherwise, personal injury or equipment
damage could occur.
The use of accessory equipment not complying with the
equivalent safety requirements of this equipment may lead to a
reduced level of safety of the resulting system. Consider the use
of the accessory in the patient’s vicinity and evidence that the
safety certifications of the accessory have been performed in
accordance with the appropriate International Electrotechnical
commission (IEC) 60601-1 harmonized national standard.
Personal injury or equipment damage could occur.
Devices connecting to the serial data port must be compliant with
EN 60601-1-2, the EMC requirement for Medical Devices.
Failure to do so could result in personal injury or equipment
damage.
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.
The equipment shall not be used adjacent to or stack with other
devices unless verification of normal operation in the
configuration in which it is to be used can be achieved.
Use only Bistos recommended fuel cells for proper operation.
Failure to do so could result in personal injury or equipment
damage.

Higher incubator relative humidity at any given temperature

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decreases an infant’s evaporative heat loss, and may cause an
increase in the infant temperature. Routinely monitor the infant’s
rectal and/or axillary temperature according to the attending
physician’s orders or Nursery Standing Orders. Failure to do so
could result in personal injury.
Higher relative humidity will, at any given time, decrease an
infant’s evaporative water loss, and may cause an increase in
infant temperature. This effect is greatest n very low birth-weight,
premature infants. The attending physician should prescribe
Temperature Control mode, temperature setting, and humidity
output level setting. Routinely monitor the infant’s rectal and/or
axillary temperature according to the attending physician’s orders
or Nursery Standing Orders. Failure to do so could result in
personal injury.
Fill the reservoir to the Maximum Filing Limit line. Do not
overfill. Water spillage may result, and personal injury could
occur.
Use distilled water only (<10 ppm total dissolved solids). The
use of sterile water is not acceptable. Equipment damage could
occur.
For proper operation of the incubator, use only skin temperature
probes from Bistos Co. Ltd. Using other probes could result in
personal injury or equipment damage.
Never place the skin temperature probe under the infant or use it
rectally. Personal injury could occur.
BT-500 cannot differentiate between an increase in core
temperature with a cold skin (fever) and a low core and skin
temperature (hypothermia). The temperature of the infant is
monitored separately.
When in skin mode, the skin temperature probe must be in direct
contact with the skin to provide accurate monitoring of the
infant’s skin temperature. When in skin mode, failure to maintain
direct skin contact can result in overheating. Routinely check the
infant’s condition for correct sensor attachment, and feel the
infant’s skin for signs of overheating.
When an x-ray is taken through the hood, the hood could show
up on the x-ray as a radiolucent shadow and could result in
incorrect diagnosis.
Do not use in the presence of flammable anesthetics. Personal
injury or equipment damage could occur.

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
Keep matches, and all other sources of ignition, out of the room
in which the incubator is located. Textiles, oils, and other
combustibles are easily ignited and burn with great intensity in
air enriched with oxygen. Personal injury or equipment damage
could occur.
Small quantities of flammable agents, such as ethyls and alcohol,
left in the incubator may cause a fire in connection with oxygen.
Personal injury or equipment damage could occur.
A fire and explosion hazard exists when performing cleaning or
maintenance procedures in an oxygen-enriched environment.
Make sure that oxygen supply is turned Off and the oxygen hose
to the incubator is disconnected when performing cleaning and
maintenance procedures. Turn off or disconnect oxygen supplies
during periods of non-use. Failure to do so could result in
personal injury or equipment damage.
If it is necessary to administer oxygen in an emergency, notify the
attending physician immediately. Failure to do so could result in
personal injury or equipment damage.
Improper use of supplemental oxygen may be associated with
serious side effects including blindness, brain damage, and death.
The risks vary with each infant. The qualified attending physician
should prescribe the method, the concentration, and the duration
of oxygen administration.
Administration of oxygen may increase the noise level for the
infant within the infant incubator.
An oxygen analyzer shall be used separately when oxygen is
delivered to the infant.
Measure the oxygen concentrations to verify delivery of the
prescribed oxygen concentration. Failure to do so could result in
personal injury or equipment damage.
If the patient’s arterial oxygen levels cannot be maintained when
the oxygen control setting is set to maximum, the attending
physician should prescribe alternate means of oxygenation.
Failure to do so could result in personal injury or equipment
damage.
The oxygen concentration inspired by an infant does not
accurately determine the partial pressure of oxygen(pO2) in the
blood. When deemed advisable by the attending physician,
measure blood pO2by accepted clinical techniques. Failure to do
so could result in personal injury or equipment damage.

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
Disconnect the incubator from the hospital oxygen source when
oxygen is not in use. Failure to do so could result in personal
injury or equipment damage.
As oxygen use increases the danger or fire, do not place auxiliary
equipment that produces sparks in an incubator. Personal injury
or equipment damage could occur.
Use of anesthetic agents can interfere with oxygen analyzer
accuracy.
Inspect gas/oxygen service components at regular service
intervals for signs of corrosion or damage. Failure to do so could
result in personal injury or equipment damage.
A dirty air intake micro filter could affect performance or cause
carbon dioxide(CO2) build-up. Ensure that the filter is checked
on a routine basis commensurate with local conditions.
Particularly, if the unit is used in an unusually dusty environment,
more frequent replacements may be necessary. Failure to do so
could result in infant injury or equipment damage.
After each change of oxygen flow, allow at least 30 min to
achieve new concentrations. Failure to do so could result in
personal injury or equipment damage.
Compressed gas cylinders, such as oxygen cylinders, can become
hazardous projectiles if the gas is released rapidly due to damage
or other causes. Securely fasten the cylinder. Failure to do so
could result in personal injury or equipment damage.
Oxygen levels within the incubator hood environment may be
affected when the access doors or access panels are opened.
Make sure all hood access door gaskets and tubing ports are
properly installed. Any open gaps in the incubator hood may
reduce the incubator’s internal oxygen. Personal injury could
occur.
Make sure all hood access door gaskets and tubing ports are
properly installed. Any open gaps in the incubator hood will
reduce the incubator’s internal relative humidity. Personal
injury or equipment damage could occur.
The use of infant seats, or other accessories within the incubator
that can alter the airflow pattern, may affect temperature
uniformity, temperature variability, the correlation of the
incubator temperature reading to center mattress temperature and
infant skin temperature. Personal injury could occur.

Phototherapy units located too close to the incubator may affect

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hood wall temperature, incubator hood temperature, and infant
skin temperature. Personal injury of equipment damage could
occur.
Phototherapy lamps placed over the top of the incubator hood
may interfere with upward travel of the vertical height adjustable
stand. To prevent this interference, always remove the
phototherapy lamp prior to positioning the stand.
If airflow passages are not kept clear of obstructions, such as
blankets and stuffed animals, during clinical usage, patient safety
and incubator performance may be compromised.
To avoid overheating the infant due to direct radiation, do not
position the incubator in direct sunlight or under other sources of
radiant heat.
Do not place surgical covers or blankets over the infant and warm
air curtain or side vents simultaneously. This may cause heat-
induced injury and burns.
To prevent accidental disconnection, secure all patient leads,
infusion lines, and ventilator tubing to the mattress with sufficient
excess length to allow for the full range of mattress height
adjustment.
Only connect equipment to the serial port that complies with the
relevant IEC standard; and use data cables with plastic body
connectors.
Do not raise the hood at any time while the infant is in the
incubator. Gain access to the infant by the access panels and
access doors. Failure to do so could result in personal injury or
equipment damage.
When the front access panel (or optional rear) is open, the
temperature display may not accurately reflect the incubator
temperature. Do not leave the front access panel (or optional rear)
open longer than essential. Personal injury could occur.
Positively secure all access panel latches to avoid accidental
opening, Failure to do so could result in personal injury or
equipment damage.
For infant safety, do not leave the infant unattended when the
access panels are open. Personal injury could occur.
Always use two people when moving the incubator and patient
together. When moving the incubator within the same floor
space, check that the patient is secured safely in the unit and

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either remove or secure all loose system components to prevent
possible patient injury or equipment damage. If the move
involves varying floor heights or a complete floor level change
(i.e. thresholds, ramps, elevators), remove all items either not
being used or not necessary for the move, lower the VHA, IV
poles and shelves to their lowest position, place all drawers in
their locked state, and remove all accessories from the front and
rear rail position.
Never place objects taller than the top of the wheel casters
beneath the incubator stand. Placement of objects there could
interfere with the stability of the vertical height adjustable stand.
Personal injury of equipment damage could occur.
To avoid possible tip-over or damage to adjacent carts, IV stands,
shelves, etc., keep at least a 12” (30 cm) perimeter area clear
around the vertical height adjustable stand.
For optimum incubator stability, always lock all stand wheels, Do
not leave the unit unattended when parking on an incline. Failure
to do so could result in personal injury or equipment damage.
When raising or lowering the incubator, the operator should
ensure that both equipment and appendages are clear of the unit’s
travel path. Patient and incubator connections must also be
checked before adjusting the incubator height. Never place any
objects on top of the drawer assembly and always check before
lowering the VH that there is sufficient clearance between the
incubator and stand assembly. Do not raise or lower the unit
while installing or removing medical gas tanks from the tank
holder assembly. Failure to do so could result in personal injury
of equipment damage.
The UART port is for debugging purposes only. It does not allow
connections with other devices.
Prior to placing the infant in the incubator, pre-warm the
incubator to the temperature prescribed by the attending
physician, or according to nursing protocol.
Only one monitor shelf should be used per incubator. When using
the monitor shelf, always place the monitor in the center of the
shelf, ensure that the monitor fits within the border of the shelf,
and avoid stacking monitors on the shelf. Personal injury or
equipment damage could occur.
Attach the incubator to the stand or the vertical height adjustable
stand using the bolts provided. Failure to do so could result in the
incubator separating from the stand if sufficiently tilted,
particularly with the hood open. Personal injury or equipment

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damage could occur.
This product has been validated with the accessories and options
listed in this manual and found to comply with all relevant safety
and performance requirements applicable to the device. It is
therefore the responsibility of that person or organization who
makes an unauthorized modification, or incorporates an
unapproved attachment to the device, to ensure that the system
still complies with those requirements.
Apulse oximeter should NOT be used as an apnea monitor
Pulse rate measurement is based on the optical detection of a
peripheral flow pulse and therefore may not detect certain
arrhythmias. The pulse oximeter should not be used as a
replacement or substitute for ECG based arrhythmia analysis.
Apulse oximeter is an early warning device. Use lab co-oximeter
to completely understand the patient’s condition.
Do not use the MS board pulse oximeter in the presence of
flammable anesthetics or other flammable substance in
combination with air, oxygen enriched environments, or nitrous
oxide.
Do not remove the monitor cover except to replace the battery.
An operator may only perform maintenance procedures
specifically described in this manual. Refer servicing to Masimo
in repair of this equipment.
Leakage current must not exceed 100 microamperes; measure
when an external device is connected to the serial port.
Do not use Masimo oximetry sensors during MRI scanning as it
could potentially cause burns.
Inaccurate measurements may be caused by incorrect application
or use.
Inaccurate measurements may be caused by significant levels of
dysfunctional hemoglobin (HbCO or MetHb).
Inaccurate measurements may be caused by intravascular dyes
such as indocyanine green or methylene blue.
Inaccurate measurements or loss of pulse signal may be caused
by excessive illumination.

Inaccurate measurements may be caused by excessive patient

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movement.
Inaccurate measurements may be caused by venous pulsation.
Inaccurate measurements or loss of pulse signal may be caused
by placement of a sensor on an extremity with a blood pressure
cuff, arterial catheter or intravascular line.
The MS board pulse oximeter can be used during defibrillation,
but the readings may be inaccurate for a short time.
Loss of pulse signal can occur when the sensor is too tight.
Loss of pulse signal can occur when the patient has hypotension,
severe vasoconstriction, severe anemia, or hypothermia.
Loss of pulse signal can occur when there is arterial occlusion
proximal to the sensor.
Loss of pulse signal can occur when the patient is in cardiac
arrest or is in shock.
Use only Masimo sensors for SpO2 measurements.

Tissue damage can occur due to incorrect placement of sensor.
1.3Shock hazards
SHOCK
HAZARD

Unplug the unit from its power source prior to cleaning or
maintenance. For units equipped with an uninterruptible power
supply(UPS) system, also remove the battery pack prior to
cleaning or maintenance. Failure to do so could result in personal
injury or equipment damage.
Some chemical cleaning agents may be conductive and leave a
residue that may permit a build-up of conductive dust or dirt. Do
not allow cleaning agents to contact electrical components, and do
not spray cleaning solutions onto any of these surfaces. Personal
injury or equipment damage could occur.
To ensure grounding reliability, plug the AC power cord only into
a properly grounded 3-wire hospital-grade or hospital-use outlet.
Do not use extension cords. If any doubt exists as to the
grounding connection, do not operate the equipment. Personal
injury or equipment damage could occur.
Do not expose the unit to excessive moisture that would allow for
liquid pooling. Personal injury or equipment damage could occur.

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
Due to the risk of electrical shock hazard, only qualified
personnel with appropriate service documentation should service
the unit.
Batteries can present a risk of electric shock. The following
precautions should be taken when working on batteries: remove
watches, rings or other metal objects; use tools with insulated
handles.
The total power of all equipment connected to the convenience
outlet strip on the pedestal / stand must me within the electrical
requirements shown on the rear of the pedestal / stand. Otherwise,
personal injury or equipment damage could occur.
Make sure the Building power source is compatible with the
electrical specifications shown on the column of the pedestal /
stand and on the incubator. Failure to do so could result in
personal injury or equipment damage.
To prevent equipment damage or accidental power
disconnections, do not plug an incubator power cord directly to
an AC wall socket when the incubator is mounted on a pedestal
/stand. Always provide power to the incubator by using the power
cord coming directly from the pedestal /stand.
1.4 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 20°C to
30°C. Operating
humidity ranges from 0%
to 95%.
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.

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1.5Definitions and symbols
Symbol
Description
Used to identify safety information.
Be well-known this information thoroughly before using BT-500.
During the operation, do not disconnect any cable.
Indicate the warning for hot surface.
Type BF Applied part
Refer to operation manual. Read manual before placing the device.
Skin temperature sensor #1, to be connected to infant’s abdomen for baby
(controlled) mode
Skin temperature sensor #2, to be connected to other than infant abdomen
IPX0
IPX0 Non-protected against ingress of water with harmful effects.
(Device)
IPX1
IPX1 Protected against the vertically dripping water
(Skin temperature sensor_2EA)
IPX2
IPX2 Protected against the dripping water
(SpO2sensor)
IPX6
IPX6 Protected against the powerful jetting
(Foot switch_2EA)
Indicates the weight limit
This symbol indicates the manufacturer.
This symbol indicates the serial number of the device.
This symbol indicates the authorized representative in the European
Community of manufacturer.
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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This symbol indicates to keep the device dry.
This symbol indicates to keep the correct upright position on the transport
package.
This symbol indicates the device is fragile.
This symbol indicates the temperature limitation for operation, transport
and storage.
This symbol indicates the humidity l
imitation for operation, transport and
storage.
This symbol indicates the packing material is recyclable.
External Signal IN/OUT Port
This symbol indicates the compliance with the essential requirements and
provisions of the Medical Device Directive 93/42/EEC as amended by
2007/47/EEC.
This symbol indicates to not dispose the device together with unsorted
municipal waste(for EU only). The solid bar symbol indicates that mains
adapter is put on the market after 13August 2005.

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Section 2
Introduction
2.1 General
This chapter provides a general description of the BT-500 infant incubator including.
Brief Device Description
Product Features
Model Configurations
2.2 Brief Device Description
A mains electricity (AC-powered) unit designed to provide an enclosed controlled
environment to maintain appropriate temperature and humidity levels mainly for premature
infants and other newborns who cannot effectively regulate their body temperature. It
typically consists of a clear removable plastic hood with a mattress. It typically includes a
means to warm the infant such as providing heated air; temperature controls that work
automatically either by measuring the air temperature or through a temperature sensor
attached to the infant skin; and humidity controls. The device is intended to use in a hospital.
2.3 Intended Use
BT-500 is an infant incubator for non-invasively measuring and showing graphically
humidity, air temperature, skin temperature, O2 Module, weight and SpO2. This data is
intended to aid the maintaining life of a premature baby or a precocious baby under 2kgs.
This device is for use only by trained medical personnel located in hospital. Also this device
can be used in the all departments of the hospital which offers a neonatal care service such
as NICU(Neonatal Intensive Care Unit), special nursery unit and pediatrics.
2.4 Operating Principles
- Air and skin temperature measurement and Control: Internal cartridge heater raises the
temperature. The infant environmental temperature value is determined by air a skin
temperature that is measured by the sensor module. Through the main fan, the air is
circulated within the hood and adjusts the temperature.
- Humidity measurement and control: The steam of humidity module vaporizes the water
particles. It Adjust the humidity mixed with air within the hood. Sterilized by heating the
water to 100℃.
- O2 Module(Optional):It is available to control the oxygen concentration in the hood when
putting the module option of oxygen concentration.
- SpO2 measurement (Optional):The probe sensor is wear at the end of an infant’s finger. By
measuring the intensity of reflected light, depending on the concentration of dissolved
oxygen in the blood determines the oxygen saturation.

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- Pulse rate measurement(SpO2):During the heart beats, the infrared light is from the light
source.
It is on the arteriole, such as fingers. The intensity of the light is reflected to the sensor is
measured.
2.5 Essential performance
Air temperature measurement and incubator air temperature control.
Skin temperature measurement and infant Skin temperature control.
Humidity measurement and control inside the incubator.
An alarm occurs if the difference between the set temperature and the control
temperature is more than a certain level.
System must remain in a safe condition acc. IEC 60601-1, IEC 60601-2-19
WARNING
Do not use the skin temperature control on babies who are in shock
or who have high temperatures
2.6 Options and Accessories
Picture
Name
Description
Qty
Control shell
(Standard)
Hold up the hood and be composed
with instruments and parts that control
the temperature and humidity 1ea
Hood
(Standard)
Made of double framed clear acrylic
panel to watch inside, and to minimize
heat loss 1ea
Fixed Stand
(Standard) Movable incubator cradle with wheels 1ea
Basket
(Optional) Storage of medical equipment and items which infant needs 1ea
Basket Partition
(Optional) Partition of Basket 1ea
Sensor module
(Standard)
Measures temperature and humidity
inside the hood and infant’s body
temperature 1ea

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Mattress tray
(Standard) Baby desk with X-ray tray 1ea
mattress
(Standard)
Accommodate infant stably with
bouncy mattress 1ea
Skin
temperature
sensor
(Standard)
Measures infant’s skin temperature 2ea
IV-pole
(Optional) IV hanger. 1ea
AC power code
(Standard) AC Power cord(AC Power cord for
operating the equipment) 1ea
External LCD
Monitor
(Optional)
Displays measured values from the
control and video of infant inside the
hood.1ea
CCD Camera
(Optional) Takes video of infant inside the hood 1ea
Masimo SpO2
sensor probe
(Optional) Measures infant’s SpO2 1ea
Masimo
Extension for
SpO2 sensor
(Optional)
Extend sensor cable 1ea
IV plate
(Optional) Plate to place items which infant needs 1ea
Shelf
(Optional) Plate to place items which infant needs 1ea

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Lift Stand
(Optional)
Movable incubator cradle with wheels
(VHA- Variable Height Adjustable) 1ea
Weighting
Scale
(Optional)
Measures Infant’s weight 1ea
2.7 Appearance of BT-500
2.7.1 BT-500 Front View
Figure 2-1. BT-500 Front view
①Control Shell ②Hood
③Sensor module ④Moving Stand
⑤Basket ⑥IV pole
⑦IV plate ⑧External monitor
Notes;
* The built-in air filter requires periodic replacement to maintain clean air periodic
replacement of the pads according to the maintenance schedule is recommended.
**Oxygen control module is also available as an optional component.