Bistos BT-550 User Manual
BT-550
Operation Manual
Keep this manual for future reference
P/N : 550-ENG-OPM-EUR-R01
BT-550 Operation manual
1
P/N : 550-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2018.03
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 Co., Ltd.
The information contained herein is subjects to change without notice.
Prepared by:
Bistos Co., Ltd.
th
7
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
Revision R01
Mar,2018
Printed in Korea
Copyright © Bistos Corporation 2018. All rights reserved.
Proprietary Material
BT-550 Operation manual
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P/N : 550-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2018.03
Contents
0. Safety information ······················································································ 4
0.1 General precautions, warnings and cautions ···························································· 6
0.2 Shock hazards ············································································································· 9
0.3 General precautions on environment ······································································· 10
1. System basics ······························································································ 11
1.1 Indication for use ········································································································ 11
1.2 Operating principle ····································································································· 11
1.3 System configurations ································································································ 12
1.4 Product outlook ·········································································································· 14
1.5 Description of system components ············································································ 15
1.6 Understanding the display ························································································· 20
1.7 Buttons ······················································································································· 21
1.8 Alarm and warning indication ····················································································· 23
1.9 Essential performance ································································································ 25
2. Operation of BT-550····················································································· 26
2.1 Precautions ················································································································· 26
2.2 Assembling BT-550 ····································································································· 27
2.2.1 Repositioning the column ·················································································· 27
2.2.2 Installing the IV pole to column (option) ··························································· 30
2.2.3 Installing the plate for auxiliary equipment to column (option) ························ 31
2.3 Separating barriers ····································································································· 32
2.4 Tilting bed ··················································································································· 33
2.5 Skin temperature sensor ···························································································· 34
2.6 Prepare to use ············································································································· 35
2.7 Operation ···················································································································· 36
2.8 SpO2 Monitor(option) ······························································································· 39
3. Placing infant and moving BT-550 ································································ 46
3.1 Placing infant ·············································································································· 46
3.2 Move the BT-550 ········································································································ 46
3.2.1 Precautions ········································································································ 46
3.2.2 Stand caster lock ································································································· 47
4. Maintenance and cleaning ·········································································· 48
4.1 Service policy ·············································································································· 48
4.2 Maintenance ·············································································································· 48
4.3 Cleaning ······················································································································· 48
5. Trouble shooting ·························································································· 50
5.1 General ······················································································································· 50
5.2 Understanding alarms ······························································································· 50
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6. Manufacturer’s declaration on EMC ·································································· 51
6.1 Electromagnetic emissions ····························································································· 51
6.2 Recommended separation distances between portable and mobile RF communications
equipment and the BT-550 ···························································································· 52
6.3 Electromagnetic immunity ······························································································ 53
7. Technical specifications ···················································································· 55
Product Warranty ·································································································· 57
Figure 1-1: Front View ··············································································································· 14
Figure 1-2: Side view ················································································································· 14
Figure 1-3: System components ································································································ 15
Figure 1-4: Head ························································································································ 16
Figure 1-5: Column ···················································································································· 17
Figure 1-6: Bassinet ··················································································································· 18
Figure 1-7: Stand part ················································································································ 19
Figure 1-8: Display when SpO
Figure 1-9: Display when SpO
Figure 1-10: Buttons ·················································································································· 21
Figure 1-11: POWER Fail ············································································································· 23
Figure 1-12: Sensor Disable ········································································································ 23
Figure 1-13: S1 Tem p Erro r ········································································································· 23
Figure 1-14: S2 Tem p Error ········································································································ 23
Figure 1-15: Baby Check ············································································································· 23
Figure 1-16: Head Rotation ········································································································ 23
Figure 1-17: Masimo Check Alarm ····························································································· 24
Figure 1-18: Masimo Alarm Message ························································································· 24
Figure 2-1: Repositioning the column (1) ·················································································· 27
Figure 2-2: Repositioning the column (2) ·················································································· 28
Figure 2-3: Repositioning the column (3) ·················································································· 29
Figure 2-4: Installing IV pole ······································································································ 30
Figure 2-5: Installing plate for auxiliary equipment ··································································· 31
Figure 2-6: Separating barriers ·································································································· 32
Figure 2-7: Tilting handles ·········································································································· 33
Figure 2-8: Skin temperature sensor ·························································································· 34
Figure 2-9: Power cord ··············································································································· 35
Figure 2-10: Product logo and initial screen··············································································· 35
Figure 2-11: Caster locks ············································································································ 47
option not installed ·································································· 20
2
option installed ········································································· 20
2
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WARNING
CAUTION
Used to identify safety information.
During the operation, do not disconnect any cable.
his symbol indicates the authorized representative in the European
0 Safety information
Before using BT-550 Infant warmer, read this entire manual and be fully understood the following
safety information to prevent injury of patient and user.
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 infant warmer. When used in conjunction with the
following words, the symbols indicate:
Can lead to serious injury or death.
Can lead to minor injury
The following symbols are placed on product, label, packaging and this manual in order to stand for
the information about:
Be well-known this information thoroughly before using BT-550.
Indicate the warning for hot surface.
IPX0 IPX0 Non-protected against ingress of water with harmful effects.
IPX1
IPX2
IPX6
IPX1 Protected against the vertically dripping water
(Skin temperature sensor_2EA)
IPX2 Protected against the dripping water
(SpO2 sensor)
IPX6 Protected against the powerful jetting
(Foot switch_2EA)
Refer to operation manual. Read manual before placing the device.
Indicates the weight limit
This symbol indicates the manufacturer.
This symbol indicates the serial number of the device.
T
Community of manufacturer.
This symbol indicates a type BF applied part.
This symbol indicates to keep the device dry.
This symbol indicates the device is fragile.
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This symbol indicates the temperature limitation for operation, transport
This symbol indicates the humidity limitation for operation, transport and
This symbol indicates the compliance with the essential requirements and
This symbol indicates to not dispose the device together with
In order to comply with EU Directive 2002/96/EC on Waste Electrical and
Electronic Equipment (WEEE): This product may contain material which
DO NOT
be RECYCLED in accordance with local regulations, contact your local
and storage.
storage.
This symbol indicates the packing material is recyclable.
provisions of the Medical Device Directive 93/42/EEC as amended by
2007/47/EEC.
unsorted municipal waste(for EU only). The solid bar symbol indicates
that mains adapter is put on the market after 13 August 2005.
DISPOSAL
could be hazardous to human health and the environment.
DISPOSE of this product as unsorted municipal waste. This product needs to
authorities for more information. This product may be returnable to your
distributor for recycling - contact the distributor for details.
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Thoroughly read and understand the manual prior to use of the BT-550. Failure
s directed by an appropriately
se of accessories other than those listed and approved for use with this
rtified accessories with the appropriate International
Medical electrical equipment needs special precautions regarding EMC and
The equipment shall not be used adjacent to other devices unless verification of
0.1 General precautions, warnings and cautions
• Examine the warmer 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
warmer if there is any visible sign of damage.
• Only the AC line cord supplied with the BT-550 is approved for use with the Unit.
• Do not attempt to service the BT-550 infant warmer. Only qualified service personnel by
Bistos Co. Ltd., should attempt any needed internal servicing.
• The BT-550 is not specified or intended for operation during the use of defibrillators or during
defibrillator discharge.
• The BT-550 is not specified or intended for operation in the presence of electrosurgical
equipment.
• The BT-550 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-550 infant warmer if it fails to pass the power on self-test procedure.
WARNING
to do so could result in personal injury or equipment damage.
Infant warmer misuse may result in harm to an infant. Only properly trained
personnel should use the infant warmer a
qualified attending physician aware of currently known risks and benefits.
U
product may result in increased emissions or decreased immunity.
Use only ce
Electrotechnical Commission (IEC) 60601 harmonized national standard.
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 affect medical electrical equipment.
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normal operation in the configuration in which it is to be used can be achieved.
could result in personal injury or
or use it
must be in direct contact with the skin to provide
Do not use in the presence of flammable anesthetics. Personal injury or
and burn with great intensity in air enriched with oxygen. Personal injury or
To avoid overheating the infant due to direct radiation, do not position the
monitor shelf, always place the monitor in the center of the shelf, ensure that
For proper operation of the infant warmer, use only skin temperature sensor
from Bistos Co. Ltd. Using other sensor
equipment damage.
Never place the skin temperature sensor under the infant’s body
rectally. Personal injury could occur.
The skin temperature sensor
accurate measurement of the infant’s skin temperature. 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.
equipment damage could occur.
Keep matches, and all other sources of ignition, out of the room in which the
infant warmer is located. Textiles, oils, and other combustibles are easily ignited
equipment damage could occur.
Small quantities of flammable agents, such as ethyl and alcohol, left on the
infant warmer 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.
infant warmer in direct sunlight or under other sources of radiant heat.
To prevent accidental disconnection when adjust the height, ensure that all
patient leads, infusion lines, and ventilator tubing have sufficient excess length.
For infant’s safety, do not leave the infant unattended. Personal injury could
occur.
Never place objects taller than the top of the wheel casters beneath the infant
warmer stand. Personal injury of equipment damage could occur.
For optimum stability, always lock all stand wheels. Do not leave the device
unattended when parking on an incline. Failure to do so could result in personal
injury or equipment damage.
Prior to placing the infant in the infant warmer, pre-warm the BT-550 to the
temperature prescribed by the attending physician, or according to nursing
protocol.
Only one monitor shelf should be used per infant warmer. When using the
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the monitor fits within the border of the shelf, and avoid stacking monitors on
manual and found to comply with all relevant safety and performance
person or organization who makes an unauthorized modification, or
550 yourself to avoid damage to the
equipment and unexpected electrical shock. Only qualified Bistos service
heck the rating of power source compatible with the input voltage rating of
materials such as watch and ring and touch only the
the shelf. Personal injury or equipment damage could occur.
Attach the infant warmer to the stand using the bolts provided. Failure to do so
could result in the infant warmer separating from the stand if sufficiently tilted.
Personal injury or equipment damage could occur.
This product has been validated with the accessories and options listed in this
requirements applicable to the device. It is therefore the responsibility of that
incorporates an unapproved attachment to the device.
An operator may only perform maintenance procedures specifically described
in this manual.
Do not remove the covers of a BT-
engineer must repair or replace components.
C
BT-550.
The UART port is for debugging purposes only. It does not allow connections
with other devices.
Take off the metallic
insulated plastic part of BT-550
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Unplug the unit from its power source prior to cleaning or maintenance to prevent
ome chemical cleaning agents may be conductive and leave a residue that may
o not allow cleaning agents to
To ensure grounding reliability, plug the AC power cord only into a properly
Do not expose the unit to excessive moisture that would allow for liquid pooling.
The total power of all equipment connected to the convenience outlet strip on the
the electrical requirements shown on the rear of the stand.
uilding power source is compatible with the electrical
0.2 Shock hazards
WARNING
personal injury or equipment damage.
S
permit a build-up of conductive dust or dirt. D
contact electrical components and do not spray cleaning solutions onto any of
these surfaces. Personal injury or equipment damage could occur.
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.
Personal injury or equipment damage could occur.
Do not touch the patient and signal input/output parts simultaneously
Due to the risk of electrical shock hazard, only qualified personnel with appropriate
service documentation should service the unit.
stand must be within
Otherwise, personal injury or equipment damage could occur.
Make sure the b
specifications shown on the column of the stand and on the infant warmer. Failure
to do so could result in personal injury or equipment damage.
To prevent equipment damage or accidental power disconnections, do not plug a
BT-550 power cord directly to an AC wall socket when the BT-550 is mounted on a
pedestal /stand. Always provide power to the BT-550 by using the power cord
coming directly from the pedestal /stand.
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Avoid placing in an area
Power off when the
0.3 General precautions 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.
where high variation of
temperature exists.
Operating temperature
ranges from 18
Operating humidity
ranges from 0 % ~ 95 %.
℃ ~ 30℃.
Avoid exposure to direct
sunlight
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 chemicals are
stored or where there is
in danger of gas leakage.
Do not disjoint or
disassemble the device.
Bistos Co., Ltd. does not
have liability of it.
Avoid placing in an area
where there is an
excessive shock or
vibration.
Avoid dust and especially
metal material enter into
the equipment
equipment is not fully
ready to operate.
Otherwise, the
equipment could be
damaged.
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1 System basics
1.1 Intended use
The BT-550 Infant Warmer is intended to emit controlled, evenly distributed overhead heat to the body
of premature infant and other newborns that cannot effectively regulate their body temperature. This
device can be used before any treatment or operation of an infant. The device has two operating
functions; the baby mode and the manual mode. In the baby mode, the temperature is controlled by
the infant’s skin temperature. The infant’s skin temperature is compared to the temperature setting. If
the measured skin temperature is lower than a temperature setting value, the warmer operates to
increase the skin temperature of an infant. In the manual mode, the warmer operates for a predefined
time.
The device has the option for weighing scale and SpO2 measuring functions. Weight and SpO2 of infant
can be measured using the options. In the SpO2 measurement, the sensor is place at the end of a
finger. By measuring the intensity of reflected light, depending on the concentration of dissolved
oxygen in the blood determines the oxygen concentration.
1) Intended patient population
- Newborns, Premature infant, Low birth weight infant
- Age up to 3 months
- Weight up to 10 Kg
2) Intended user profile
- Nursing staff or physicians who is qualified personnel
- Basic experiences or knowledge on medical field, especially on obstetrics
- Trained or requested to read IFU before use
3) Environment of use
- Hospital (birthing center, delivery rooms), Neonatal intensive care unit (NICU)
- Requirements: Stable power source
1.2 Operating principle
The BT-550 infant warmer is electrically powered device with a radiant heating source intended to
maintain the thermal balance of an infant by direct radiation of energy in the infrared region of the
electromagnetic spectrum. The maximum irradiance level at any point on the mattress is 100% heater
output, 28 ㎽/㎠±20% in the total infrared spectrum.
The following graph shows the emissivity data of infrared radiation used for the BT-550 Infant Warmer.
It has the specific frequency band of 2 ~ 11㎛.
BT-550 Operation manual
12
P/N : 550-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2018.03
1.3 System configurations
Basic configuration of BT-550
• Main body with fixed height stand
• Mattress & Power cable
• 2 skin temperature sensor
Options of BT-550
• Motor-driven height adjustable stand (Lift stand)
• Intravenous(IV) pole
• IV Plate for auxiliary equipment
• Basket(Drawer)
• Basket partition
• Weighing scale
• Bed tilting mechanism
• SpO
2
• Extension for SpO2 sensor
BT-550 Operation manual
13
P/N : 550-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2018.03
Picture
Name
Description
Qty
Masimo
(Optional)
Fixed Stand
(Standard)
Mattress
(Standard)
Skin temperature
sensor (Standard)
AC power code
(Standard)
Masimo SpO2
sensor probe
(Optional)
Extension for
SpO2 sensor
Movable warmer cradle with wheels 1ea
Accommodate infant stably with
bouncy mattress
1ea
Measures infant’s skin temperature 2ea
AC Power cord(AC Power cord for
operating the equipment)
1ea
Measures infant’s SpO2 1ea
Extend sensor cable 1ea
Weighting Scale
(Optional)
Basket (Optional)
Basket Partition
(Optional)
IV-pole
(Optional)
IV plate
(Optional)
Lift Stand
(Optional)
Measures Infant’s weight 1ea
Store medical equipment and items
which infant needs
1ea
Partition of Basket 1ea
IV hanger 1ea
Plate to place items which infant
needs
Movable warmer cradle with wheels
(VHA- Variable Height Adjustable)
1ea
1ea
BT-550 Operation manual
14
P/N : 550-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2018.03
1.4 Product outlook
Basic configuration Configuration with full Options
Figure1-1: Front view
Figure1-2 : Side view
BT-550 Operation manual
15
P/N : 550-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2018.03
Equipped with infrared radiating light source and can be rotated
Supporting head part and equipped with electronic circuits to
he electronic circuits are composed with
side of column when the option has been selected.
Equipped with mattress and protective barriers to prevent the
easy access to infant patient.
1.5 Description of System components
①
②
③
④
Figure1-3: System components
Name Description
Head
up to 90° to left and right each and totally 180°.
operate BT-550 inside. T
Column
power supply part, display and user interface.
The IV pole and plate for auxiliary equipment attached on the
Supporting the whole BT-550 system. Basic stand has fixed
height. Height adjustable stand is available as option.
Stand
It has equipped with caster to move the BT-550 easily and can be
fitted with drawer and bed tilting mechanism when options are
selected.
patient from falling off the mattress. X-ray cassette tray is located
Bed
under the bed for X-ray procedure. Weighing scale plate can be
placed beneath the mattress as option.
Protective barriers can be opened or removed from the bed for
BT-550 Operation manual
16
P/N : 550-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2018.03
Examination
lamp
Ventilation
hole
Figure1-4: Head
①
②
③
④
Name Description
Alarm light Flashing red light in alarm status
Heat source
Composed with heating element, reflecting plate and
protection guard to prevent touch the heating element
Provide added illumination of the mattress area
To ventilate the heated air around the heating element
BT-550 Operation manual
17
P/N : 550-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2018.03
WARNING
The maximum permitted load of IV pole is 5 kg. Do not hang heavy object on
place heavy object on the plate.
Figure1-5: Column
① IV Pole
②
Display LCD
③ B
uttons
④
Power switch
⑤ C
onnector for SpO2 sensor and weighing scale
⑥
Connector for Skin temperature sensor
⑦ P
late for auxiliary equipment (IV Plate)
⑧
Speaker
the pole.
The maximum permitted load of plate for auxiliary equipment is 11 kg. Do not
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