Bistos BT-500 User Manual

P/N : 500-ENG-OPM-EUR-R12

BT-500

Infant Incubator Operation Manual

Keep this manual for future reference

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 permissio n from Bistos Co., Ltd

Informatio n furnished by Bist os Co., Ltd is believed to be accurate and reliable . However, no responsibility is assumed by Bistos for its use, or any infringeme nts of pate nts or o ther right s of third parties tha t may re sult fro m its use. No license is granted by implication or otherwise under any patent or patent rights of Bistos.

Revision 12 July, 2019

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Table of Contents

1 Safety

1.1 Instructions for the safe operation and use of the device

1.2 Warnings

1.3 Shock hazard

1.4 General precautions on environment

1.5 Symbols

2 Introduction

2.1 General

2.2 Brief device description

2.3 Intended use

2.4 Operating principles

2.5 Essential performance

2.6 Accessaries and options

2.7 Appearance of device

2.7.1 Front view

2.7.2 Front view detail

2.7.3 Rear view

2.7.4 Side view

2.8 Description of each part

2.8.1 Control shell

2.8.2 Hood

2.8.3 Mattress tray

2.8.4 Stand

3 Install and connection

3.1 IV pole assembly

3.1.1 IV external monitor

3.1.2 IV plate

3.1.3 IV ringer pole

3.2 Air filter assembly

3.3 Connection of power and cable

3.3.1 Power connection

3.3.2 Cable connection

3.3.3 Sensor module connection

3.4 Placement of infant

3.5 Movement and installation

4 Operation

4.1 System start-up

4.2 LED

4.3 Key and knob operation

4.3.1 Key

4.3.2 Knob

4.4 Displays

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4.5 Temperature measurement and control

4.6 Humidity Measurement and control

4.7 O

measurement

4.8 Weighing scale measurement

4.9 SpO

and Pulse rate measurement

4.10 Menu function

4.11 Pulse oximeter

4.12 External monitor

4.13 Shut down

4.14 Calibration of O

module

5 Alarms

5.1 System alarms

5.2 Temperature alarms

5.3 Humidity alarms

5.4 Oxygen alarms

5.5 Weighing scale alarms

5.6 Alarm self-test

6 Cleaning & Maintenance

6.1 General cleaning method and precautions

6.2 Hood

6.3 Shell, sensor module, scale module and basket

6.4 Water tank

6.5 Skin temperature sensor and SpO

sensor

6.6 Drain of residual water

6.7 Regular inspection

6.8 Battery replacement and disposal

6.9 Disposal of the device

7 Specification 8 Troubleshooting

8.1 General checking

8.2 Alarm message checking

9 Declaration on EMC

9.1 Electromagnetic emissions

9.2 Recomended separation distances between portable and mobile RF

communications equipment and the device

9.3 Electromagnetic immunity

Warranty

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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.

Be informed that it may cause serious electrical shock to the patient

HAZARD” sign.

WARNING

Thoroughly read and understand the manual prior to use of the incubator.

ubator misuse may result in harm to an infant. Only properly trained

d approved for use in this

The total electrical current leakage of all items powered through the

120V AC/ 100V AC systems and less than 500uA for 230V AC systems.

1 Safety

1.1 Instructions for the Safe Operation and Use of the device

 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.

SHOCK HAZARD

1.2 Warnings



or operator, property damage, material losses against the “SHOCK

Failure to do so could result in personal injury or equipment damage.)

 Inc

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 an

product as original or replacement items may result in increased emissions or decreased immunity.



incubator, including devices on the outlet strip, must be less than 300uA for

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Otherwise, personal injury or equipment damage could occur.

The use of accessory equipment not complying with the equivalent safety

resulting system. Consider the use of the accessory in the patient’s vicinity and evidence that the safety certifications of the accessory have been

Devices connecting to the serial data port must be compliant with EN

2, the EMC requirement for Medical Devices. Failure to do so could

Medical electrical equipment needs special precautions regarding EMC and

provided in this manual. In addition, portable and mobile RF

temperature. Routinely monitor the infant’s rectal and/or axillary temperature according to the attending physician’s orders or Nursery

decrease an infant’s

evaporative water loss, and may cause an increase in infant temperature.

weight, premature infants. The

attending physician should prescribe Temperature Control mode,

midity output level setting. Routinely monitor

the infant’s rectal and/or axillary temperature according to the attending

ling Limit line. Do not overfill. Water

incubator, use only skin temperature probes

from Bistos Co. Ltd. Using other probes could result in personal injury or

Never place the skin temperature probe under the infant or use it rectally.



requirements of this equipment may lead to a reduced level of safety of the

performed in accordance with the appropriate International Electrotechnical commission (IEC) 60601-1 harmonized national standard. Personal injury or equipment damage could occur.



60601-1result in personal injury or equipment damage.



needs to be installed and put into service according to the EMC information

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 decreases an

infant’s evaporative heat loss, and may cause an increase in the infant

Standing Orders. Failure to do so could result in personal injury.

 Higher relative humidity will, at any given time,

This effect is greatest n very low birth-

temperature setting, and hu

physician’s orders or Nursery Standing Orders. Failure to do so could result in personal injury.

 Fill the reservoir to the Maximum Fi

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

equipment damage.



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Personal injury could occur.

differentiate between an increase in core temperature with a

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

Do not use in the presence of flammable anesthetics. Personal injury or

enriched environment. Make sure that oxygen

when performing cleaning and maintenance procedures. Turn off or

If it is necessary to administer oxygen in an emergency, notify the attending

Administration of oxygen may increase the noise level for the infant within

entrations to verify delivery of the prescribed

oxygen concentration. Failure to do so could result in personal injury or

 BT-500 cannot

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

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.



equipment damage could occur.

 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 oxygensupply is turned Off and the oxygen hose to the incubator is disconnected

disconnect oxygen supplies during periods of non-use. Failure to do so could result in personal injury or equipment damage.



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.



the infant incubator.

 An oxygen analyzer shall be used separately when oxygen is delivered to the

infant.

 Measure the oxygen conc

equipment damage.

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If the patient’s arterial oxygen levels cannot be maintained when the oxygen

The oxygen concentration inspired by an infant does not accurately

that produces sparks in an incubator. Personal injury or equipment

Inspect gas/oxygen service components at regular service intervals for signs

lter could affect performance or cause carbon

commensurate with local conditions. Particularly, if the unit is used in an

y be

necessary. Failure to do so could result in infant injury or equipment

After each change of oxygen flow, allow at least 30 min to achieve new

projectiles if the gas is released rapidly due to damage or other causes.

are properly

internal relative humidity. Personal injury or equipment damage could

The use of infant seats, or other accessories within the incubator that can



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.



determine the partial pressure of oxygen(pO2) in the blood. When deemed advisable by the attending physician, measure blood pO techniques. Failure to do so could result in personal injury or equipment damage.

 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 of fire, do not place auxiliary equipment

damage could occur.

 Use of anesthetic agents can interfere with oxygen analyzer accuracy.



of corrosion or damage. Failure to do so could result in personal injury or equipment damage.

 A dirty air intake micro fi

dioxide(CO2) build-up. Ensure that the filter is checked on a routine basis

by accepted clinical

unusually dusty environment, more frequent replacements ma

damage.



concentrations. Failure to do so could result in personal injury or equipment damage.

 Compressed gas cylinders, such as oxygen cylinders, can become hazardous

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

installed. Any open gaps in the incubator hood will reduce the incubator’s

occur.



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alter the airflow pattern, may affect temperature uniformity, temperature variability, the correlation of the incubator temperature reading to center

temperature, incubator hood temperature, and infant skin temperature.

ps 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

stuffed animals, during clinical usage, patient safety and incubator

and ventilator tubing to the mattress with sufficient excess length to allow

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

tional rear) is open, the temperature

bator and patient together. When moving the incubator within the same floor space, check that the patient is secured safely in the unit and either remove or secure all loose system components to prevent possible patient injury or equipment

ove 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

mattress temperature and infant skin temperature. Personal injury could occur.

 Phototherapy units located too close to the incubator may affect hood wall

Personal injury of equipment damage could occur.

 Phototherapy lam

positioning the stand.

 If airflow passages are not kept clear of obstructions, such as blankets and

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

of side vents simultaneously. This may cause heat-induced injury and burns.

 To prevent accidental disconnection, secure all patient leads, infusion lines,

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.



could result in personal injury or equipment damage.

 When the front access panel (or op

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

 For infant safety, do not leave the infant unattended when the access panels

to do so could result in personal injury or equipment damage.

are open. Personal injury could occur.

 Always use two people when moving the incu

damage. If the m

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their lowest position, place all drawers in their locked state, and remove all

Never place objects taller than the top of the wheel casters beneath the

etc., keep at least a 12” (30 cm) perimeter area clear around the vertical

timum incubator stability, always lock all stand wheels, Do not leave

and incubator connections must also be checked before adjusting the

while installing or removing medical gas tanks from the tank holder

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

efore the responsibility of

Pulse rate measurement is based on the optical detection of a peripheral

accessories from the front and rear rail position.



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,

height adjustable stand.

 For op

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

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

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.



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 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 ther 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.

 A pulse oximeter should NOT be used as an apnea monitor



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flow pulse and therefore may not detect certain arrhythmias. The pulse

oximeter to

Do not use the MS board pulse oximeter in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen

Do not remove the monitor cover except to replace the battery. An operator may only perform maintenance procedures specifically described in this

e current must not exceed 100 microamperes; measure when an

Do not use Masimo oximetry sensors during MRI scanning as it could

Inaccurate measurements may be caused by significant levels of

Inaccurate measurements may be caused by intravascular dyes such as

Inaccurate measurements or loss of pulse signal may be caused by

ement of a sensor on an extremity with a blood pressure cuff, arterial

Loss of pulse signal can occur when there is arterial occlusion proximal to

n occur when the patient is in cardiac arrest or is in

oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis.

 A pulse oximeter is an early warning device. Use lab co-

completely understand the patient’s condition.



enriched environments, or nitrous oxide.



manual. Refer servicing to Masimo in repair of this equipment.

 Leakag

external device is connected to the serial port.



potentially cause burns.

 Inaccurate measurements may be caused by incorrect application or use.



dysfunctional hemoglobin (HbCO or MetHb).



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 movement.

 Inaccurate measurements may be caused by venous pulsation.



plac 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.



the sensor.

 Loss of pulse signal ca

shock.

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Use only Masimo sensors for SpO2 measurements.

Tissue damage can occur due to incorrect placement of sensor.

SHOCK

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

al cleaning agents may be conductive and leave a residue that

Do not expose the unit to excessive moisture that would allow for liquid

Batteries can present a risk of electric shock. The following precautions

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

Make sure the Building power source is compatible with the electrical

incubator. Failure to do so could result in personal injury or equipment

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.



1.3 Shock hazards



HAZARD

could result in personal injury or equipment damage.

 Some chemic

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.



pooling. Personal injury or equipment damage could occur.

 Due to the risk of electrical shock hazard, only qualified personnel with

appropriate service documentation should service the unit.



should be taken when working on batteries: remove watches, rings or other metal objects; use tools with insulated handles.



damage could occ u r.



specifications shown on the column of the pedestal / stand and on the

damage.

 To prevent equipment damage or accidental power disconnections, do not

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Power off when the

could be damaged.

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 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 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 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.

equipment is not fully installed. Otherwise, the equipment

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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.

ates the authorized representative in the European Community of

This symbol indicates the compliance with the essential requirements and provisions of the

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 13

1.5 Symbols

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 (SpO2 sensor)

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 indic manufacturer.

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 limitation for operation, transport and storage.

This symbol indicates the packing material is recyclable.

External Signal IN/OUT Port

Medical Device Directive 93/42/EEC as amended by 2007/47/EEC.

August 2005.

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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, O 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 or skin temperature that is measured by the sensor module. Through the main fan, the air is circulated within the hood and controls the temperature.

 Humidity measurement and control: The steam of humidity module vaporizes the water

particles. It control the humidity within the hood. The water is sterilized by boiling it to 100℃.

 O

Module (Optional): The oxygen concentration in the hood is controlled when the oxygen

option was attached.

 SpO2 measurement (Optional): The SpO

installed. The probe sensor is applied to the end of an infant’s finger. By measuring the intensity of reflected light which is dependent on the concentration of dissolved oxygen in the blood, the oxygen saturation can be determined.

 Pulse rate measurement (PR): During the SpO

pulsates by the heartbeat. By measuring this pulsation, the device can determine the pulse rate of the subject.

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 control temperature and the reading

Module, weight and SpO2. This data is intended to aid the

of infant can be measured when the option was

measurement, the light reflected by blood is

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WARNING

Do not use the skin temperature control on babies who are in shock or who have high

Picture

Name

Description

Qty

Hold up the hood and be composed with

and humidity

medical equipment and items which

Measures temperature and humidity inside the AC Power cord(AC Power cord for operating the

temperature is more than a certain level.

 System must remain in a safe condition acc. IEC 60601-1, IEC 60601-2-19

temperatures

2.6 Accessories and options

Control shell

(Standard)

Fixed Stand

(Standard)

(Optional)

Partition

(Optional)

module

(Standard)

Hood

Basket

Sensor

instruments and parts that control the temperature

Made of double framed clear acrylic panel to watch inside, and to minimize heat loss

1ea

Movable incubator cradle with wheels 1ea

Storage of infant needs

1ea

Partition of Basket 1ea

hood and infant’s body temperature

1ea

Mattress tray

(Standard)

mattress

(Standard)

Baby desk with X-ray tray 1ea

Accommodate infant stably with bouncy mattress 1ea

Skin

temperature

sensor

Measures infant’s skin temperature 2ea

(Standard)

IV-pole

(Optional)

IV hanger. 1ea

AC power

code

(Standard)

equipment)

1ea

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Displays measured values from the control and

Masimo

(Optional)

Notes;

External LCD

Monitor

(Optional)

video of infant inside the hood.

1ea

CCD Camera

(Optional)

Masimo SpO2

sensor probe

(Optional)

Extension for

SpO2 sensor

IV plate

(Optional)

Shelf

(Optional)

Lift Stand

(Optional)

Takes video of infant inside the hood 1ea

Measures infant’s SpO

Extend sensor cable 1ea

Plate to place items which infant needs 1ea

Movable incubator cradle with wheels (VHAVariable Height Adjustable)

1ea

Weighing

Scale

(Optional)

Measures Infant’s weight

1ea

* 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.

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Control Shell

① Console box

① Rear access door

2.7 Appearance of BT-500

2.7.1 Front View

① ② Hood ③ Sensor module ④ Moving Stand ⑤ Basket ⑥ IV pole ⑦ IV plate ⑧ External monitor

2.7.2 Front View Detail

2.7.3 Rear view

Figure 2-1. Front view

② Water tank draw ③ Tilting mechanism handle ④ Hood handle ⑤ Front access door ⑥ Baby desk with X-RAY tray ⑦ Weighing scale ⑧ Compatible mattress

Figure 2-2. Front view details

② AC power cord & connector

Figure 2-3. Rear view

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Sensor module, SpO2 sensor &

2.7.4 Side view

①

external communication port

② Main power switch ③ Main power AC connector ④ Incubator handle

2.8 Description of each part

Figure 2-4. Left view

Figure 2-5. Right view

BT-500 is composed with several parts. The control shell is the part which controls the entire device.

To measure the infant’s environment, the sensor module is needed. The hood is used to protect an

infant from the external environment and maintain the internal environment of hood to best

condition.

2.8.1 Control shell

The control shell part consists of console box and water tank.

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WARNING

To prevent accidental disconnection, secure all access panel latches. Failure to do

Figure 2-6. Control Shell

The water tank has a 1 Liter capacity. The reservoir permits visual

inspection of the water level. It is located in a drawer in the front of

the shell. When the drawer is closed and the latching handle is

engaged, the reservoir is connected to heater module.

For more information about how to clean, see "Chapter 6 cleanliness

and maintenance”

2.8.2 Hood

The hood of BT-500 is an acrylic material. There is Access door in the front, rear and both sides of

hood.

Figure 2-8. Hood front view & Access door / side function

so could result in personal injury of equipment damage.

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 Rotate the pawl latches, and open the front

latches until they are fully engaged.

WARNING

When raising or lowering the incubator, the operator should ensure that both

could result in personal injury of equipment damage.

2.8.3 Mattress tray

access panel.

 Pivot the front access panel to the full open

position (hanging straight down).

 Slide out the mattress tray to the fully extended

position (up to 22cm).

 Carefully lean on the mattress tray to ensure it is

properly supported and provides a firm infant platform.

 Return the mattress tray.  Close the front access panel, and rotate both

2.8.4 Stand

Max. to 220mm

Weight limit : under 20kg

BT-500 has two types of stand as fixed and lifting. Following figure show the fixed stand. In case of lifting type, you are able to adjust the vertical height using two sets of up/down arrow on

footswitch. (VHA - Variable Height Adjustable) This type is optional. The height of the stand can be

adjusted if necessary by stepping on an appropriate side of the pedal for height adjustment.

Figure 2-12. Fixed Stand (Standard)



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 VHA that there is sufficient clearance between the incubators 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

Figure 2-13. Lifting Stand (Optional)

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① IV ringer pole assembly

3 Install and Connection

Attention to follow direction for installing BT-500.

 Use this device in 20~30 ℃ of environmental temperature and 0~90 % of humidity.  Check the connection of the AC power cord and then use this cord,  Caution to this device because of easy to break.  When connecting AC power cord, connect the one electrical outlet and infant incubator.  Install the main body on horizontal location.  Do not use the electrical cord connected to generate a noise.  Install away from dust or inflammable material

3.1 IV pole Assembly

The IV poles can be mounted as below. Check each Part name and number

② IV plate assembly ③ IV external monitor assembly ④ Shelf

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LCD monitor assembly (1ea)

① IV plate bolt (1ea), hexagon wrench

Ringer pole (1ea)

3.1.1 IV External monitor

3.1.2 IV plate

3.1.3 IV ringer pole

① ② Machine screw M5x5 (3ea), Hexagon

wrench 2.5mm

③ IV LCD pipe, 25.4mm (1ea) ④ Machine screw M3x12 (4ea), pan head ⑤ IV LCD frame (1ea) ⑥ Lock washer M6 (2ea) ⑦ Screw M6x25 (2ea), Hexagon wrench

5mm

⑧ LCD monitor assembly cable (1ea)

② IV plate (1ea) ③ IV plate bushing, 2T (1ea) ④ IV plate support, 5T (1ea) ⑤ IV pole guide (2ea) ⑥ Socket screw M5x5 (8ea), hexagon wrench

2.5mm

⑦ Machine screw M3x12, pan head (4ea) ⑧ IV plate pole, 25mm (1ea) ⑨ Machine screw M3x18, pan head (4ea)

⑩ Spring washer M3 (4ea) ⑪

Lock washer M6 (2ea)

IV plate frame (1ea)

⑫

Screw M6x25 (2ea), hexagon wrench

⑬

5mm

① ② IV ringer pipe, 25.4mm (1ea) ③ Machine screw M3x12, pin head (4ea) ④ IV LCD frame (1ea) ⑤ Lock washer M6 (2ea) ⑥ Screw M6x25 (2ea), hexagon wrench

5mm

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Total assembly

WARNING

Air filter exchange period is once in 3 month. Please check frequently and

Connect 110V or 220V AC power cord to power,

3.2 Air Filter Assembly

① ② Micro filter (1ea) ③ Filter cover (1ea)

④ Filter cover bolt (2ea)



carefully that it is not dirty.

3.3 Connection of Power and Cable

3.3.1 Power Connection

and connect the code to the power input terminal

one side of the body below the BT-500 body. At

that time, make sure latch the cord by using the

locking device for prevent of unexpected

separation. Afterward, it is operated by pushing

the power switch located at the bottom of the

front of the device as shown.

When power is supplied normally, the power

indicator LED is lit and Self-test screen appears at

the same time.

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Connect all probes and cables to the sensor part in the

WARNING

When inserting or removing the connectors, be careful not to put or pull the

so could result in personnel injury or equipment damage.

Connect the sensor module as shown. Remove the

WARNING

Prior to placing the infant in the incubator, pre-warm the incubator to the

protocol.

3.3.2 Cable Connection

hood and left and rear part of stand as shown.



cable by force or twist it. Be sure to confirm the position, direction and shape and to pull lightly the locking metal part of the end of the cable. Failure to do

3.3.3 Sensor Module Connection

connector of the sensor module. While pulling the

both guide locks, pull the sensor module out of the

hood.

3.4 Placement Infant

To place an infant in the incubator, perform the following:

1) Pre-warm the incubator.

2) Rotate the pawl latches and open the front access door of hood.

3) Place the infant on the center of the mattress carefully.

4) Close the access door and ensure the pawl latches are fully engaged.



temperature prescribed by the attending physician, or according to nursing

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WARNING

Never move the incubator when there is an infant in the incubator.

damage.

To place the BT-500 in desired place,

CAUTION

Install the incubator on a horizontal and stable place. Step on the two

when there is difficult to disconnect from the supply mains.

3.5 Movement and lock

To move the position of incubator, perform the following:

1) Identify that infant is not in incubator.

2) Turn off all accessories plugged into the stand receptacles and remove accessories and items not

in use during movement.

3) In case of VHA, adjust the stand to its lowest position prior to move the equipment.

4) Coil up the power cord and secure it.



 Always push or pull the incubator forward or backward in a straight line

along the length of the stand (from the ends). Lateral or angular movement (across the width) can result in inadvertent tip-over if the wheels encounter any obstacle. Personnel injury or equipment damage could occur.

 Always use two people when moving the incubator. When moving the

incubator within the same floor space, And 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.

 Always close and latch drawers when not in use and particularly when the

incubator is being moved.

 For optimum stability, always lower the incubator to its lowest position prior

to transport. Make sure that items placed on the monitor shelf are properly secured. Failure to do so could result in personal injury or equipment

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.



stoppers to lock the casters securely. To move the incubator to another place, be sure to unlock the casters.

 The AC power plug is a means to isolate its circuits electrically from the

supply mains on all poles simultaneously. Do not place the device in an area

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connection may differ depending on the

4 Operation

4.1 System Start-up

1) Turn on the power switch in the bottom

left of the BT-500 front.

2) Then check the following logo is

displayed in the main LCD.

3) Make sure the system check screen is

being output. Make sure each piece of

equipment is functioning properly. The

options and modules connected or not.

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Control panel

4) Ensure that the various items properly

output to the main display screen of the

product. If the O

control option has

been added to the main display screen

it can be changed to control the O

concentration inside the incubator.

4.2 LED

The following symbol s are f u nctions and descriptions of LEDs on the control panel.

Symbol Name Description

[Mute]

[Keylock] Lock the Key, used to unlock it. When key is locking, LED is on.

[Override] In override mode, LED is on.

[AC power]

If the key beep is on, whenever you push any keys the beep sounds.

To use control panel, you must unlock the key lock function first. This is the protective method of

misuse or unintended operation. To unlock the key locking function, you should use [Keylock]

When alarm situation is activated, using this key you can off the sound for a certain time. In this case, LED is off.

In case of AC power cord is disconnected by accident, LED is blinking.

Table 4-1. Function of LED

key.

When you push [Keylock] key, LED is off. Then you can go into mode setting and setting of control

parameters.

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Symbol

Name

Description

Use this key to select the parameter for set-up.

Use this key to silent during a period of time in case of

Display window

Action

Description

Control

Rotate CW

+0.1 ℃ or +1 %

Rotate CCW

-0.1 ℃ or -1 %

Push

Select options / Finish selecting options

Rotate(CW/CCW)

Shift options and change setting value

4.3 Key and knob operation

4.3.1 Key

[Parameter]

Use this key to select the temperature, humidity

(option : select the oxygen concentration)

[Mode] Use this key to select control mode.

[Up] Use this key to raise the parameter’s value.

[Down] Use this key to lower the parameter’s value.

[Enter]

Use this key to enter the parameter’s value to control mode.

[Menu] Use this key to enable the use of Knob to select menu options.

[Mute]

the alarm situation.

[Keylock] Use this key to Lock or unlock.

Table 4-2. Use of Key

4.3.2 Knob

Not only Knob is used for changing the setting value, but also it can be used for shifting and changing

the Menu options. For changing the setting value, when the setting is complete, setting value is

reflected to control by pushing. For using the purpose of Menu option, you should [Menu]

when key locking is released.

Following table shows how to handle knob in each case.

setting value

4.4 Displays

BT-500 provides the one display screen and the one dynamic Menu window together. Figure 4-6 is the

basic layout of BT-500.

Push Reflect setting value.

Table 4-3. Use of Knob

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Figure 4-6. Main operation display

Figure 4-7. Basic screen of Main display (O2 control available)

① Air temperature region

This region displays the measured air temperature in the hood. Celsius(℃) or

Fahrenheit(℉) can be displayed according to set. In case of module failure, connection failure and senor failure is indicated by “--.-”.

Note: In this region, current heater power is displayed by gauge

② Skin temperature region

This region displays the patient’s skin temperature in the hood. Celsius(℃) or Fahrenheit(℉)

can be displayed according to set. The case of module failure, connection failure and senor failure is indicated by “--.-”.

③ Humidity region

This region displays the measured relative humidity in the hood. Correct unit

is %RH and % is displayed only.

Note: In this region, current water level is displayed by gauge.

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In this region, according to control mode, especially air mode, user is able to set the

user is able to set the patient’s skin temperature in the hood. At this time,

setting value that is lower than outer temperature. Also user can set the relative humidity in the hood.

This region displays the lists of items regarding

value and PR(pulse rate)

with unit(%, bpm). When the signal is not

Temperature Setting Value

Humidity Setting Value

④ Setting region

temperature in the hood. In case of skin mode,

equipment does not control the temperature

⑤ SpO2 region

the SpO2. SpO2 extracted from SpO2 waveform are displayed

setting value Pulse rate value

SpO

measured, it is indicated as “---”.

⑥ O2 region

This region displays the O2 concentration by the % unit in the hood When the O2 sensor has malfunction or disconnection, it is indicated as “-- ”. When the O2 sensor reaches the saturating concentration, it is indicated as “**”.

⑦ Scale region

This region displays weight of infant. When the scale module has malfunction or disconnection, it is indicated as ” -.---”

⑧ Status region

This region displays the Date/Time, patient ID, control mode icon, override mode icon, Keylock icon, and Sound icon. In control mode, there are air mode and skin mode and configuration color is changed by modes status. In override mode, air mode, if setting temperature is above 37.1 ℃, skin mode, if setting temperature is above 37.6 ℃, the setting can be executed with [keylock] key. In case of sound icon,

Press the [Mute key]

Following table indicates the function of icon used in the status region.

Icon Name Description

Air mode icon Control mode status : Air mode

Skin mode icon Control mode status : Skin mode

Humidity mode icon Control mode status: Humidity mode

Trend icon Trend indication

O2 icon O2 indication

SpO2 icon SpO2 indication

button to pause the alarm sound in case of the alarm situation.

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Air/Skin temperature Override mode icon

1) To unlock the key, push the [keylock] key. (red underline

key or rotate CW the knob to raise the setting

or rotate CCW the knob to

hood is controlled automatically.

PR icon Pulse rate indication

Weight icon Weighing scale indication

Key lock icon Key is locking.

Key unlock icon Key input is enable..

Air/Skin temperature Override mode On.

Alarm on icon Alarm Sound on.

Alarm off icon Alarm Sound off.

4.5 Temperature Measurement and Control

 Measurement: Measurement of air temperature and skin temperature are starting at the same

time of BT-500 power on. In case of skin temperature, especially, metal part of skin temperature sensor probe must be attached to the infant’s abdomen.

 Setting and Control

① Air mode: The measured value is displayed on air temperature region in upper left of screen

and the setting value is displayed on setting region in upper right of screen with blue.

on setting value)

2) Push the [Up] key or rotate the knob CW to raise the

setting temperature from 23.0℃ to 37.0℃ in 0.1℃ increments. In temperature override mode, push the [Up]

temperature from 37.1℃ to 39.0℃.

Push the [Down] key lower the setting temperature from 39.0℃ to 23.0℃ in

0.1℃ increments.

3) To confirm the setting value and lock the key, push the

[keylock] key.

4) According to this value, the temperature of inside of the

Note: When key locking is released, LED is off and key lock icon is removed. Also, if no keys are

pushed or knob is rotated within 10s of selecting display, it is automatically locked.

② Skin mode: The measured value is displayed on skin temperature region in upper middle of

screen and the setting value is displayed on setting region in upper right of screen with yellow.

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1) To unlock the key, push the [keylock] key. (red underline on

CW the knob to raise the setting temperature from 37.6˚ to

When using two skin temperature sensors, it is displayed as

1) To unlock the key, push the [keylock] key. (red underline on

hood is controlled automatically.

WARNING

Premature neonates below 30 weeks may need humidity over 80% for long

water vapor on the wall because of possible bacterial colonization.

setting value) By pushing [Mode] key , change control mode status.

2) Push the [Up] key

setting temperature from 35.0˚ to 37.5˚ in 0.1˚ increments.

or rotate the knob CW to raise the

In temperature override mode, push the [Up] key or rotate

39.0˚.

Push the [Down] key or rotate CCW the knob to lower

the setting temperature from 39.0˚ to 35.0˚ in 0.1˚

increments.

3) To confirm the setting value and lock the key, push the

[keylock] key.

4) To maintain the infant’s body temperature, the

temperature of inside of the hood is controlled automatically.

shown. In order to use skin mode as the control mode, skin temperature 2 should be removed.

4.6 Humidity Measurement and Control

 Measurement: Humidity measurement starts at the same time when BT-500 is powered on.  Setting and Control: The measured value is displayed on humidity region in upper middle of

screen and the setting value is displayed on setting region in upper right of screen with sky-blue.

setting value) By pushing [Parameter] key , change the parameter.

2) Push the [Up]

or [Down] key or rotate the knob to raise or lower the setting humidity from 40% to 95% in 1%p increments.

3) Push the [Enter] button for reflecting set-up and push the

[keylock]

4) According to this value, the relative humidity of inside of the

key to lock.



periods of time. In this high humidity environment, water vapor condensation could build up inside hood surface and prolonged condensation can lead to rain-out or watery surface underneath mattress. It is highly recommended that user should prevent water vapor condensation by controlling temperature and humidity and clean out

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 Measurement: O2 concentration in the hood begins automatically

in upper right of screen with green.

1) To unlock the key, push the [keylock] button. (red underline

value automatically.

WARNING

Oxygen flow rate cannot guarantee the accuracy of oxygen concentration

Oxygen concentration should be continuously measured by calibrated

An oxygen analyzer shall be used separately when oxygen is delivered to

equipment that produces sparks in an incubator. Personal injury or

damage.

 Measurement: Weighing measurement starts at the

Kg or pound unit according to set record.

4.7 O2 Measurement and Control

starting operation at the same time. The measured value is displayed on O2 region in the lower of screen with green.

 Setting and Control: The measured value is displayed on O2 region

in the lower of screen; setting value is displayed on setting region

on setting value) By pushing [Parameter] key , change the parameter.

2) To unlock the key, push the [Keylock] key

. (red underline

on setting value)

3) To change the setting mode, push the [Parameter] key

Setting mode is Temperature, Humidity, Oxygen sequentially.

4) To set the key, push the [Up]

, [Down] key or

control knob key to set the O2 concentration unit 1%

5) Press the [Enter] key

the [Keylock] key

to reflect the setting and then press

to lock.

6) Adjust the O2 concentration in accordance with the setting



in the incubator.



oxygen analyzer.

 Administration of oxygen may increase the noise level for the infant within

the infant incubator.



the infant.

 Use of anesthetic agents can interfere with oxygen analyzer accuracy.  As oxygen use increases the danger of fire, do not place auxiliary

equipment damage could occur.

 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

4.8 Weighing Scale Measurement

same time when BT-500 is powered on. Measured data continuously displayed on lower part of screen in white

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Measurement: To measure SpO2,

screen in white(SpO2) and blue(PR).

Functions of system, alarm, trend, and modules are able to be set and

After pushing the [keylock] key to unlock,

rotation of the Knob is used to shift between menu options and pushing is used to reflect the setting value. When the cursor is located on arrow, you

You can change Temperature unit, Weight

around with noise level more than 66dB.

The silence period of alarm can be set

You can set the delay time 0,5,10 and

levels.

4.9 SpO2 and PR(pulse rate) Measurement



apply the probe to the patient’s toe or earlobe. The exact applied part is decided according to the medical opinion. The measured value is displayed on SpO2 region in lower of

4.10 Menu functions

changed by using Menu options. press the [menu] key to go to the menu function.

To change and move to other category, use Control Knob. CW or CCW

can move to other menu category tabs.

① System

unit, Language, Time and Warm-up mode. There are 3 different kind of warm-up mode Silent, Normal, and Fast Mode.

 Silent: Warm-up time will take 1 hour

around with noise level less than 45dB.

 Normal: Warm-up time will take 45Min

around with noise level less than 55dB.

 Fast: Warm-up time will take 25Min.

② Alarm

to 5, 10, 20 30, and 60 minutes. For the silence period, alarm sound is silent and silent time is displayed on main display. SpO2 Alarm delay refers to the delay time after an alarm condition occurs, an alarm sounds until the occurrence.

15 seconds. And you can set PR Beep volume level. There are 5 different volume

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Trend period is set as 9, 18, 36, and 72

Trend display

The calibration of O2(21%, 100%, weight is available. Select the O2 setting mode or measured

xternal monitor in

the monitor mode function. Read the chapter 4.11

Below table is the description of SpO2 setting

This mode is provides the best combination of sensitivity and

the majority of patients.

This mode should be used for the sickest patients, where

clinician and patient contact is continuous.

③ Trend

hours and it is displayed on main display. Also each trend display data are possible to enable or disable: air temperature, skin temperature, humidity and oxygen. These trend display datum are displayed on main operation display with setting period.

④ Modules

mode of main display. And select the Cam mode, Graph mode, Masimo mode of e

to understand explanation of each monitor mode. In addition, set the Cam. Hor. Mirror to reverse the display from side to side.

⑤ SpO2

menu. Please refer to below table to set SpO2 settings. Changed setting will be apply on SpO and display on external monitor, please refer to

4.11 for external monitor explanations.

Items Description

sensitivity

Normal

probe-off detection performance. This mode is recommended for

Algorithm

mode

Maximum sensitivity

APOD This mode is the least sensitive in picking up a reading on patients

obtaining a reading is most difficult. Maximum Sensitivity is designed to interpret and display data for even the weakest of signals. This mode is recommended during procedures and when

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with low perfusion but has the best detection for prove-off

risk of the sensor becoming detached. (Pediatric, combative, etc. )

2 seconds

4 seconds

8 seconds

10 seconds

12 seconds

14 seconds

16 seconds

SpO2

limit

BT-500 provide the simple

conditions. This mode is useful for patients that are at particular

averaging

⑥ Help

information about the equipment. The information is as follow:

 parts of full set BT-500  main control panel and

 how to use and change

FastSat

ON This mode is always on for 2-4 and 4-6 averaging modes.

OFF -

SpO2

alarm

PR Alarm

limit

Low If the SpO2 value is lower than this value, an alarm is occurring.

High If the PR value is higher than this value, an alarm is occurring.

Low If the PR value is lower than this value, an alarm is occurring.

main display

mode and parameters

SpO2 averaging time

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WARNING

⑦ Scale : If weighing scale module is connected, a menu of weight calibration appears. Press

the [keylock] key

to unlock and press the [Menu] key more than 2 seconds then,

the menu will be displayed.

4.11 Pulse O xim et er

• Pulse oximeter of BT-500 must be operated by qualified personnel only.

Pulse oximetry is a continuous and non-invasive method of measuring the level of arterial oxygen

saturation in blood. The measurement is taken by placing a sensor on a patient, usually on the

fingertip for adults, and the hand or foot for neonates. The sensor is connected to the pulse oximetry

instrument with a patient cable. The sensor collects signal data from the patient and sends it to the

instrument. The instrument displays the calculated data in two ways: 1) as a percent value for arterial

oxygen saturation (SpO

), and, 2) as a pulse rate (PR).

- Operating Principles

: The BT-500 MS board pulse oximeter is based on three principles:

1. Oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light

(spectrophotometry).

2. The volume of arterial blood in tissue and the light absorbed by the blood changes during

the pulse (plethysmography).

3. Arterio-venous shunting is highly variables and that fluctuating absorbance by venous

blood is a major component of noise during the pulse.

The pulse oximeter of BT-500 as well as traditional pulse oximetry determines SpO

by passing red and

infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle.

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Red and infrared light-emitting diodes (LEDs) in oximetry sensors serve as the light sources, a

photodiode serves as the photodetector.

Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are caused by

oscillations in the arterial blood volume. This assumes that the blood flow in the region of the sensor

passes entirely through the capillary bed rather than through any arterio-venous shunts. The

traditional pulse oximeter calculates the ratio of pulsatile absorbance (AC) to the mean

absorbance(DC) at each of two wavelengths, 660 nm and 905 nm:

S(660) = AC(660) / DC(660)

S(905) = AC(905) / DC(905)

The oximeter then calculates the ratio of these two arterial pulse-added absorbance signals:

R = S(660) / S(905)

This value of R is used to find the saturation SpO

in a look-up table built into the oximeter’s software.

The values in the look-up table are based upon human blood studies against a laboratory co-oximeter

on healthy adult volunteers in induced hypoxia studies.

The Masimo SET MS board pulse oximeter assumes that arterio-venous shunting is highly variable and

that fluctuating absorbance by venous blood is the major components of noise during the pulse. MS

board decomposes S(660) and S(905) into an arterial signal plus a noise component and calculates the

ratio of the arterial signals without the noise:

S(660) = S1 + N1

S(905) = S2 + N2

R = S1 / S2

Again, R is the ratio of two arterial pulse-added absorbance signals and its value is used to find the

saturation SpO

in an empirically derived equation into the oximeter’s software. The values in the

empirically derived equation are based upon human blood studies against a laboratory co-oximeter on

healthy adult volunteers in induced hypoxia studies.

The above equations are combined and a noise reference (N’) is determined:

N’ = S(660) – S(905) x R

If there is no noise N’ = 0: then S(660) = S(905) x R which is the same relationship for the traditional

pulse oximeter.

The equation for the noise reference is based on the value of R, the value being seeked to determine

the SpO

between 1% and 100% and generates an N’ value for each of there R-values. The S(660) and S(905)

signals are processed with each possible N’ noise reference through and adaptive correlation

canceler(ACC) which yields an output power for each possible value of R(i.e., each possible SpO

1% to 100%). The result is a Discrete Saturation Transform (DST™) plot of relative output power versus

possible SpO

. The MS board software sweeps through possible values of R that corresponds to SpO2 values

from

value as shown in the following figure where R corresponds to SpO2 = 97%:

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WARNING

Do not remove the grounding conductor from the power plug on any

must be intact and undamaged.

The DST plot has two peaks: the peak corresponding to the higher saturation is selected as the SpO2

value. This entire sequence is repeated once every two seconds on the most recent four seconds of

raw data. The MS board SpO

therefore corresponds to a running average of arterial hemoglobin

saturation that is updated every two seconds.

- Grounding

Connect the oximeter only to a three-wire, grounded, hospital-grade receptacle. The three-conductor

plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is no

available, a qualified electrician must install one in accordance with the governing electrical code.



circumstances.

 Do not use extension cords or adapters of any type. The power cord and plug

If there is any doubt about the integrity of the protective earth conductor arrangement, operate the

oximeter on internal battery power until the AC power supply protective conductor is fully functional.

- Patient Isolation

To ensure patient electrical isolation, connect only to other equipment with electronically isolated

circuits.

Note: Do not connect to an electrical outlet controlled by a wall switch or dimmer.

- Cabling entanglement/strangulation

As with all medical equipment, carefully route patient cabling to reduce the possibility of patient

entanglement or strangulation.

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WARNING

Do not place the monitor or external power supply in any position that might

or patient cable; use only the handle on the monitor

Air temperature, skin temperature, humidity,

Plethysmograph, and SIQ). If there’s some alarms,

Masimo mode”.



cause it to fall on the patient. Do not lift the monitor by the power supply cord

- RS-232 & Alarms

RS-232 System Interconnection. Consult IEC-601-1-1 for system interconnection guidance. The specific

requirements for system interconnection are dependent upon the device connected to the MS board

pulse oximeter and the relative locations of each device from the patient, and the relative location of

the connected device to the medically used room containing the MS board pulse oximeter. In all

circumstance the MS board pulse oximeter must be connected to a grounded AC power supply. The

MS board pulse oximeter is referred to as an IEC 60601/F device in the summary of situations table

contained in IEC 60601-1-1.

Check alarm limits each time the MS board pulse oximeter is used to ensure that they are appropriate

for the patient being monitored.

4.12 External Monitor

BT-500 uses external 7” Color TFT LCD monitor that displays measured values from the control and video of infant inside the hood. Cam mode, Graph mode and Massimo mode are shown as below.

(1) Cam Mode

oxygen concentration and Weighing scale are displayed on external monitor with real-time video of infant. There’s no information for the Masimo board. If there’s some alarms, it would display message “Check alarm on Masimo mode”.

(2) Graph Mode

oxygen concentration and Weighing scale, SpO2 and PR are displayed on external monitor with real-time video of infant. Also, graphs of each parameter are displayed. There’s no information for the Masimo board. It just displays basic parameter (SpO

it would display message “Check alarm on

, PR,

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Air temperature, skin temperature, humidity,

(3) Masimo Mode

oxygen concentration and Weighing scale are basically displayed. SpO2 and PR are mainly displayed.

- Parameter Region

- Information Region

- PPG and SIQ Region

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RED

YELLOW

RED

RED RED

RED

- Alarm messages on Alarm Region

Messages display Messages display

- Board failure & Diagnostic Failure code Region

Display when the event occurred. If no failure, it would be blanked. Each description about error codes is explained in Section 8.

4.13 Shut down

To ensure safe terminating operation of BT-500, follow as below.

1) Turn off the Power switch to power down the incubator.

2) Turn off the main power source.

4.14 Calibration of O2 module

Follow the direction to set and control O

Calibration of O

concentration 21 %: Calibrate O2 concentration to atmospheric oxygen

concentration as the standard.

1) Move the position of the sensor module to O

occurred. But if sensor module relocates normal position after calibration, it operates normally.

2) To unlock the key, push the [keylock]

concentration for improving accuracy in the hood of BT-500.

calibration position. At this time, alarm can be

button. (red underline on setting value)

3) Press the [Menu]

button to enter the menu category. Select the O2 Calibration category

in [modules] catego r y.

4) Handle the knob to select the 21 % Calibration category. Push the knob to compete the

calibration.

5) If it is indicated as “Done” massage, calibration completes the work.

Otherwise, it is indicated as “Fail” massage, check the O

sensor and atmospheric oxygen

whether normal concentration.

6) Move the sensor module to normal position.

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Calibration of O2 concentration 100 %: Calibrate O2 concentration to 100 %. Calibration of O2 concentration 100 % should be performed after Calibration of O

concentration 21% is completed.

1) Move the position of the sensor module to O

calibration position. Sensor module and “O2

calibration kit” place tight. At this time, alarm can be occurred. But if sensor module relocates normal position after calibration, it operates normally.

2) Connect “O

Pressure of O

3) Turn "Sealing valve" clockwise to close contact with the sensor module and the "O

calibration kit”to be injected 100% O2 concentration. Set oxygen flow to 0 PLM.

is between 40PSI(275kPa) and 50PIS(344kPa)

Calibration Kit".

4) Be careful not to obstruct the "O

5) Inject oxygen into “O

calibration kit” At this time, the flow rate set between 5 LPM and 7

LPM (Litter Per Minute). Inject oxygen from 5 minute to 6minute to recognize O

calibration kit" of ”O2 outlet”

sensor fully.

6) To unlock the key, push the [keylock] button. (red underline on setting value)

7) Press the [Menu]

button to enter the menu category. Select the O2 Calibration category

in [modules] category.

8) Handle the knob to select the 21 % Calibration menu. Push the knob to compete the

calibration.

9) If it is indicated as “Done” massage, calibration completes the work.

Otherwise, it is indicated as “Fail” massage, check the O

sensor and atmospheric oxygen

whether normal concentration.

10) Move the sensor module to normal position.

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Alarm of BT-500 indicates the failure condition of

Followings are types of alarm message.

System alarms

Situation of pressing the key button more than 1 minute

Problem with not working or malfunction of impeller

Required to remove the skin

mode control.

5 Alarms

equipment. According to each alarm condition, alarm messages are displayed on the front LCD. At the same time, alarm sound is caused and sensor module’s LED blinks. Also all setting values for alarm condition do not changed by any interrupt such as power on and off.

Alarm pop-up window is activated in the center of the display as shown in case of the alarm situation as shown.

5.1 System alarms

This alarm is activated when disorder is occurred during operation of equipment. It is possible there will be a delay of 1 second to determine and check an accurate alarm condition.

Messages Display Sound

O O O Problem with main motor

O O O Problem with main heater

O O O Problem with water heater

O O O

LED

flash

Descriptions

Problem with air humidity measurement sensor in the hood

Problem with air temperature measurement sensor in the hood

Problem with power of impeller motor

Problem with skin temperature probe

O O O

Table 5-1. System alarm message

temperature sensor 2 during skin

When the sensor module is disconnected

Sensor module is not placed in the proper position.

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Temperature alarms

LED

flash

If the temperature measured is

2.5 ℃

If the measured temperature is

1.5 ℃

If the temperature measured is

2.5 ℃

If the measured temperature is

1.5 ℃

1) In case the measured

temperature is over 37 ℃.

1) In case the measured

temperature is over 37 ℃.

1) In case the measured

temperature is under 37 ℃.

When Hood doors are open or close, BT-500 shows the condition through icons instead of alarm sound.

Front and rear doors are open.

Front and rear doors are close open

Door open/close icon

Table 5-2. Door Open/Close Icon

Front door is open.

Rear door is open.

5.2 Temperature alarms

This alarm is activated when either disorder is occurred measuring air temperature in the hood or body temperature and difference of constant figure and over in setting temperature value.

Messages Display Sound

O O O

lower than the set temperature over

higher than the set temperature over

Descriptions

O O O

lower than the set temperature over

higher than the set temperature over

temperature reaches more than

℃ when the setting

38 temperature is under 37 ℃.

2) In case the measured

temperature reaches more than

when the setting

39 ℃

temperature reaches more than

℃ when the setting

38 temperature is under 37 ℃.

2) In case the measured

temperature reaches more than 39 ℃

when the setting

O O O

temperature reaches 37.5 ℃ ±0.5 ℃

when the setting

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2) In case the measured

37 ℃.

Humidity alarms

LED

flash

There is no water in the internal water tank.

Oxygen alarms

LED

flash

If the measured values of the two O2

certain concentration

Measured O2 concentration is lower

5 %

Measured O2 concentration is higher

5 %

Weighing Scale alarms

LED

flash

Weigh in excess of 10kg is on the mattress.

temperature reaches more than

℃ ±0.5 ℃ when the

39.5 setting temperature is over

Table 5-3. Temperature alarm message

5.3 Humidity alarms

This alarm is activated when humidity in the hood is lower than setting value or there is no water in the tank.

Messages Display Sound

O O O

Table 5-4. Humidity alarm message

Measured value is lower than setting value over 5%p.

Descriptions

5.4 Oxygen alarm

The alarm will be activated when there are differences between setting O2 concentration range and O2 concentration inside of hood. It may be activated when there is malfunction on O2 control module.

Messages Display Sound

O O O

O O O If O2 Control module is disconnected

O O O

In case there is problem with power of O2 control module.

Sensor is a difference more than a

Descriptions

5.5 Weighing Scale alarms

This alarm is activated when the measured weight is not in the measurable range which means an object other than infant is placed on the mattress.

Messages Display Sound

O O O

Table 5-5. Oxygen alarm message

O X X

Table 5-6. Weighing alarm message

than setting O2 concentration over

Descriptions

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WARNING

Do not place the monitor or external power supply in any position that might

before being used again.

5.6 Alarm self-test

The self-testing is necessary for the alarm system to check whether the performance of the audible and visible alarms has degraded over time.

 System alarm

After removing the sensor module from the top of hood, check the followings. The message

is displayed on LCD with the audible alarm. Also, the red LED flashes on

the sensor moduel connector.

 Power fail alarm

If the power cable is disconnected with power on, the LCD screen turns off and the red LED flashes with a continuous audible alarm.

Note: A fully charged battery should supply the power failure alarm for approximately 30 minutes.

If the alarm is tested for the full 10 minutes, BT-500 must be run at least 3 hours to recharge the battery before it is used to the patient. Total recharge time is 5 hours when the main power switch is on.



cause it to fall on the patient. Do not lift the monitor by the power supply cord or patient cable; use only the handle on the monitor

 Do conduct Alarm self-test whether the alarm function is working properly

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WARNING

Do not immerse the sensor in water, solvents, or cleaning solutions. Do not

Do not immerse the patient cable in water, solvents, or cleaning solutions (the

ter proof). Do not sterilize by irradiation,

Incubator should be thoroughly cleaned and disinfected after each baby is

cause an infection of patient.

6 Cleaning & Maintenance

This chapter contains instructions for the care and cleaning of the BT-500 unit and its accessories.

The BT-500 requires proper care and preventive maintenance. This ensures consistent operation and maintains the high level of performance necessary.

6.1 General cleaning method and precautions

(1) Cleaning Methods

 You can maintain the cleanliness using various methods. Though, to avoid the damages or

contamination, use the following recommended methods. .

 Clean up with warm water and detergent.  Clean completely the incubator after each baby is discharged and before being used again.  If you use the materials (unauthorized materials) that can cause damage to the device, it is

impossible to get free repair service although the device is in warranty period.

 Do not use steam cleaning the all parts of incubator. The excessive moisture can cause

damage.

 Please maintain cables with no dust and soil. And clean cables with wet fabric (water

temperature is about 40˚C / 104℉). Please clean cables using clinical alcohol once in a week.

 Do not immerse the device or sensor in liquid or a cleanser. Also all liquid must not be

permitted to enter in the device or sensor.

 When cleaning the surface of the air circulation well, take care to prevent liquids from

entering the motor. Then, dry with a clean cloth or paper towel.

 When you clean the sensor module, inner and outer wall of the hood, do not use alcohol that

can cause crazing (small stress crack) of the clear acrylic.



sterilize by irradiation, steam, or ethylene oxide.



patient cable connectors are not wa steam, or ethylene oxide.



discharged and before being used again. If patient is cared for in an incubator for more than 7 days without the device being cleaned or disinfected, it may

(2) Maintenance Methods

 Once a month, rub the main body and accessories using soft fabric with alcohol. Do not use

thinner, lacquer, ethylene or oxidant.

 After using the device, please store the device where the place has -20˚C~+60˚C of

temperature and 0%~95% of humidity.

 Restrict the device be used by doctors and nurses only.

6.2 Hood

Keep the external surface clean and free of dust, dirt, and residual liquids. Clean with a damp cloth using mild soap and water or hospital approved, nonabrasive disinfectants.

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WARNING

Turn off the BT-500 and unplug the BT-500 from the AC power source and

hood.

WARNING

Turn off the BT-500 and unplug the BT-500 from the AC power source. Do not

Be careful not to have a burn when clean the radiator of shell. Check the temperature of the radiator before cleaning.

CAUTION

Take extra care when cleaning the display surfaces, which are sensitive to

WARNING

Do not remove and clean the humidity module in operation.

and the water

Do not autoclave the components of device, except for water tank specifically identified in this chapter.

WARNING

All Masimo sensors and accessories listed to be available for device.



detach all accessories before cleaning. Do not immerse the unit in water or allow liquids to enter the case.

 Do not use alcohol for cleaning. Alcohol can cause crazing of the clear acrylic

6.3 Shell, Sensor module, Scale module, Basket

Keep the external surface clean and free of dust, dirt, and residual liquids. Clean with a damp cloth using mild soap and water or hospital approved, nonabrasive disinfectants.



immerse the unit in water or allow liquids to enter the case.

 Do not allow liquids to enter when clean the console box. Failure to do so could result

in personal injury or equipment damage.



rough handling. Rub the lens that covers them with a soft, dry cloth.

6.4 Water tank

Maintain inside of the water tank clean from the dust, the residue, the remaining liquid. Use the mild soap, water, non-abrasive sanitizer approved in the hospital and wipe with damp cloth. Also, the water tank can be disinfected by using autoclave

  The humidifier reservoir (water tank) should be cleaned

changed every day.



6.5. Skin temperature sensors and SpO2 sensors.

Keep the external surface clean and free of dust, dirt, and residual liquids. Clean with a damp cloth using mild soap and water or hospital approved, nonabrasive disinfectants



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The residual water in the humidity module can cause bacteria multiplication or equipment damage

shown in the figure. Place the water tank more

WARNING

The humidity module can be sufficiently hot to cause burns.

WARNING

The operation of each part should be checked every time before the device is

ng it immediately, and contact our distributor in local

6.6 Drain of residual water

when it is frozen. When the infant leave the hospital or the equipment not being used, remove the residual water in the humidity module as follows:

1) To cool down the humidity module, turn off

the BT-500 and remove water tank and wait about 60 minutes.

2) Remove the basket from the bottom side as

than 1L capacity below the drain valve.

3) Remove the drain valve from shell bottom

using spanner.

4) Waiting until no more water has fall down

from the drain and turn on the BT-500.

5) Press down the [Parameter] key

than 5 seconds and the system will ask the password. Enter [0,0,1,1] to start the heater operated to remove the moisture from humidity module. For drying out the humidity module, the heater will be operating about 4minutes and 40 seconds. Be careful the heated vapor can be expelled at the drain valve.

6) The BT-500 will be reset. Turn the power off

and assemble the drain valve as reverse order.

  The hot water can be poured from drain valve.

6.7 Regular Inspection

Similar to most medical equipment, BT-500 has to be inspected periodically on an annual basis in general. Refer to the service manual which is supported by Bistos Co.,Ltd. about inspectional items. Regular inspection must be performed by the company’s technician. The user and operator must not disjoint or remodel the device.



 The operation of each function should be checked every three-month in

used to patient.

general.

 If any defect should be detected in an inspection, indicate on the unit that it is

out of order, stop usi area.

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CAUTION

The internal battery must be handled by the company’s technician only. Do

In order to comply with EU Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE): This product may contain material which

dous to human health and the environment. DO NOT

to be RECYCLED in accordance with local regulations, contact your local

6.8 Battery Replacement and Disposal

If a loss of battery operation run time is noticed, the battery could possibly require replacement. When disposing or replacing of internal Li-ion battery, adhere to all applicable laws regarding recycling. Avoid storing battery above 140°F. If clothing or skin comes in contact with material from inside the battery, immediately wash with plenty of clean water.



not attempt to open the BT-500.

The internal battery is consumables. Therefore the operation time by the battery can be decreased. If the operation time is not long enough, please contact service center and change the battery. If this system is used with not sufficient operating time by the internal battery, it is possible to be shut down the system because of the lack of the internal battery’s capacity. This situation can cause not intended stop of measuring and monitoring function.

6.9 Disposal of the BT-500

When disposing of the BT-500, adhere to all applicable laws regarding recycling. If you are not able to dispose the BT-500 or you need a help for disposing the BT-500, please contact us. In the case of there are no appropriate ways to dispose, we will pick up the BT-500 for you.

DISPOSAL

could be hazar DISPOSE of this product as unsorted municipal waste. This product needs

authorities for more information. This product may be returnable to your distributor for recycling - contact the distributor for details.

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Physical characteristics

Standard

Dimension: 1,024(W)x690(D)x1,354(H)mm Weight: Approx. 99.3 Kg

Full loaded (including IV pole, IV plate, plate, external LCD

stand, O2 control module and check valve)

Dimension: 1,441(W)x797(D)x1,500(H)mm

Body (Shell + Hood)

Dimension: 1,024(W)x604(D)x773(H)mm Weight: Approx. 52.7 Kg

Fixed stand

Dimension: 1,009.5(W)x815(D)x645(H)mm Weight: Approx. 36 Kg

Lifting stand

Dimension: 1,441(W)x797(D)x1,500(H)mm Weight: Approx. 40.5 Kg

IV plate

Dimension: 479(W)x402(D)x756.4(H)mm Weight: Approx. 5 Kg

Plate

Dimension: 402(W)x302(D) Weight: Approx. 11 Kg

IV pole

Dimension: 300(W)x310(D)x718 ~ 1,068(H)mm Weight: Approx. 2.5 Kg

External 7” color TFT LCD

Dimension: 364.7(W)x35(D)x839(H)mm

Swivel angle: +180˚/ -140

Shelf

Dimension: 219(W)x334(D)x36(H)mm

Weight limit: approx. 3 Kg

Basket

Dimension: 464.2(W)x490.5(D)x241.3(H)mm

Weight limit: approx. 10 Kg

Basket partition

Dimension: 391(W)x205(D)x53(H)mm Weight: Approx. 0.45 Kg

Weighing scale

Dimension: 810(W)x400(D)x46.6(H)mm CCD camera (NTSC or PAL)

Dimension: 69.1(W)x46(D)x38(H)mm

Resolution: 510x492 pixel

Sensor module

Dimension: 157(W)x119.2(D)x64.5(H)mm Weight: Approx. 270 g

Sensor module & CCD camera assembly

Dimension: 194(W)x119.2(D)x81(H)mm Weight: Approx. 310 g

SpO2 probe

Wire length: 1,000 mm Weight: approx. 30 g

SpO2 probe extension

Wire length: 3,080 mm Weight: approx. 30 g

Mattress

Dimension: 727(W)x377(D)x27(H)mm

O2 control module

Dimension: 300(W)x170(D)x180(H)mm Weight: Approx. 760 g

Check valve

Dimension: 330(W)x365(D)x65(H)mm Weight: Approx. 460 g

7 Specifications

Weight: Approx. 117.5 Kg

monitor, shelf, weighing scale, CCD camera, lifting

Safe working load: approx. 156.5 Kg

Weight: Approx. 3 Kg Tilt angle: +30˚/ -50˚

Weight: Approx. 2.7 Kg

Weight: Approx. 4.3 Kg

Weight: Approx. 5.8 Kg

Measurement range: 0 ~ 10 Kg, ±50g

Weight: Approx. 40 g

Weight: Approx. 30 g Tilt angle: ±12˚

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Functional Characteristics

Air temperature: control and measurement of air temperature in the hood

Control range

Normal mode: 23.0 ℃ ~ 37.0 Override mode: 37.1 ℃ ~ 39.0 ℃

Measurement range

20.0 ℃ ~ 45.0 ℃

Accuracy

Skin temperature: control and measurement of skin temperature of the infant

Control range Override mode: 37.6 ℃ ~ 39.0 ℃

Measurement range

25.0 ℃ ~ 45.0 ℃

Accuracy

Accuracy of skin temperature sensor

Humidity: control and measurement of relative humidity in the hood

Control system

Steam humidifier

Control range

40 %RH ~ 95 %RH

Measurement range

15 %RH ~ 99 %RH

Accuracy

Autoclavable water box

O2: measurement of O2 in the hood

Measurement range

18 % ~ 100 %

Accuracy

O2: servo control of O2 in the hood

Control range

21 % ~ 65 %

Accuracy Max inlet pressure

120 psi

Hose diameter

8mm, 9.5mm, 11mm, 13mm (Use only oxygen hose)

Weighing scale: measurement of weight of the infant

Measurement range

0.000 Kg ~10.000 Kg

Accuracy

Pulse rate(PR): measurement of pulse rate of the infant

Measurement range

30 bpm ~ 240 bpm

Error tolerance

± 3 digit

Resolution

1 bpm

SpO2: measurement of SpO2 of the infant

Measurement range

1 % ~ 100 %

Accuracy (Without movement noise)

70 % ~ 100 %, ± 3 digit 0 % ~ 69 %, unspecified

Resolution

1 %

Power (AC)

Internal battery

Input

AC 100/240, 50/60Hz

Li-ion rechargeable battery (3.7V, 2600mAh)

Consumption

1200VA

5 hours to full charge when main power switch is on. Alarm sounds for 30 minutes while no power

Operation environment

Storage environment

Temperature

20 ~ 30°C (68 ~ 86°F)

Temperature

–20 ~ 60°C (4 ~ 140°F)

Humidity

0 ~ 95% non-condensing

Humidity

0 ~ 95% non-condensing

Air pressure

70~106 kPa

Air pressure

70~106 kPa

Altitude

0 - 2,000m(0 – 6,561.68 ft)

Altitude

0 - 2,000m(0 – 6,561.68 ft)

Other environment

<0.5% at a point 15cm above from the center of the mattress

Air velocity over the mattress

<0.3 m/s

℃

± 0.5 ℃

Normal mode: 35.0 ℃ ~ 37.5℃

± 0.5 ℃

± 0.3 ℃

± 5 %p

± 50 g

Maximum carbon dioxide(CO2) concentration

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Normal mode: 45 minutes, <55 dBA

Fast mode: 30 minutes, >66 dBA

Under 45 dBA in environmental sound pressure level

40 dBA

Standard

Complies with IEC60601-1, IEC60601-1-2, IEC60601-2-19

Class I equipment & Internal powered equipment

Continuous operation

Type BF applied part

Skin temperature probe: IPX1

Foot switch: IPX6

Alarm signal sound pressure

Priority

High (All)

Measured sound pressure level

73 dBA

A-weighted background level

48 dBA

Warm-up time

Sound pressure level in hood

SpO2 probe: IPX2

Silent mode: 60 minutes, <45 dBa

≤

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Alarm

Messages

Main heater overheated caused by

motor or thermostat malfunction

Check the fuse F1 of BD-500-MAIN.

If not, replace the humidity module.

Check the fuse F1 of BD-500-MAIN.

If not, replace the humidity module.

8 Troubleshooting

8.1 General Checking

When the following problems are happened, before contact the head office, please check following measures.

1. When you can’t power on the device.

• Please check that an adaptor of the device is connected to the AC connector properly.

• Please check the LED in the front panel is green or yellow.

2. When values are not displayed

• Please check that sensor and extension cables are properly connected to sensor connector.

• Please check that sensor works properly after connect cables.

3. When values are not in proper range

• Please check if the hood is closed well.

• Please check the probe is attached properly.

• When setting the scale to zero or measuring weight, please check if any object is placed on

the measuring plate.

If the unit has trouble, check the possible cause in sequence from above.

8.2 Alarm Message Checking

If the BT-500 has some problem for operation, it display alarm messages as below.

- Alarm messages on Main Display

Cause Solution

Motor Failed Motor driver malfunction Replace the main board (BD-500-MAIN)

Overburned

Heater

Humidity Heater

failed

Heater system

failed

Stuck key Key or knob is stuck.

Air sensors

failure

Sensor mod

disconnected

Sensor module

not in position

the broken impeller of Main fan

Water heater of humidity module malfunction

Main heater of shell malfunction

Air temperature sensor malfunction

Disconnected the sensor module Connect the sensor module to shell.

Sensor module not in position on hood

Stop the operation of BT-500 and contact to the distributor or BISTOS.

If the fuse F1 is broken, replace it.

Check key and knob if they are stuck. Replace U3 of BD-500-CPU CTRL.

Replace CIR-500-sensor sub or CIR-500sensor

Check the position of the sensor module.

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Skin Probe Disconnect

Fan power

failure

In Skin mode, Skin sensor probe is disconnected from connector. .

Fan power system malfunction Replace the main board (BD-500-MAIN)

- Alarm messages on Alarm Region of External Monitor

Alarm Messages Solution

Bad Sensor ID offset

Open LEDs

Short detector

Interference detected

Shorted LEDs

No adhesive sensor

Check the sensor status. If you are not able to comprehend the causes, connect the service personnel.

No cable

No sensor connected

Connect the skin sensor probe, or change the control mode to air mode.

Sensor off patient

Too much ambient light

Unrecognized sensor

Low SpO2

High pulse rate

Check the patient status.

Low pulse rate

- Error codes of External Monitor

If the external monitor displays alarm error codes such as board failure codes and diagnostic failure codes as below. For this, connect the service personnel immediately.

Board Failure Codes Meaning

32 DSP: Checksum failure

33 DSP: Program memory test failure

34 DSP: Data Memory test failure

35 DSP: Detector ADC Interrupt Test Failure

36 DSP: MCU Interrupt failure

Diagnostic failure Code Meaning

37 DSP : Diag queue Overrun

38 DSP : Hardware Status Failure

39 DSP : Raw Queue Overrun

40 DSP: MCU Watch Dog Failure

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0001 LED Ground

0002 Reference Voltage

0004 Digital Voltage

0008 DSP Voltage

0010 Positive LED Voltage

0020 Red current level

0040 IR Current level

0080 Digital ground

0100 Positive Preamp voltage

0200 Preamp

0400 Positive Detector voltage

0800 Negative Detector voltage

1000 LED current

2000 Analog ground

4000 LED drive voltage

8000 Sensor ID

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The essential performance of the BT-500, Infant

The BT-500 is suitable for use in all establishments

9 Declaration on EMC

BT-500 needs special precautions regarding EMC (Electromagnetic compatibility) and needs to be used according to the EMC information provided in this user manual. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect the BT-500 and should be kept at least 1 m away from the equipment.

9.1 Electromagnetic emissions

The BT-500 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-500 should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

incubator, is to provide an enclosed controlled environment to maintain appropriate temperature

RF emissions CISPR 11

Group 1

and humidity levels for infant. So there is no intentional or controlled RF emission for it’s intended performance. Therefore, its RF emissions are very low and are not likely cause any interference with nearby electronic equipment.

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations / flicker emissions IEC 61000-3-3

Class A

Complies

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 purpose.

Warning: This BT-500 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-500 or shielding the location.

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The BT-500 is intended for use in an electromagnetic environment in which radiated RF

Separation distance according to frequency of transmitter

800 MHz to 2.5 GHz

0.01

0.1

100

NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected

9.2 Recommended separation distances between portable and mobile RF communications equipment and the BT-500

disturbances are controlled. The customer or the user of the BT-500 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BT-500 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter

[W]

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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.

150 kHz to 80 MHz

0.12 0.12 0.23

0.38 0.38 0.73

1.2 1.2 2.3

3.8 3.8 7.3

12 12 23

80 MHz to 800 MHz

[m]

by absorption and reflection from structures, objects and people.

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IEC 60601

Electromagnetic environment -

Electrostatic

±8 ㎸

Floors should be wood, concrete Electrical fast

Mains power quality should be Surge

230 V~ 50 ㎐ Power

±1 kV line(s) to line(s)

Mains power quality should be

Voltage dips, short

100V~ 50 ㎐,

Mains power quality should be

Power frequency

30A/m

Power frequency magnetic fields

9.3 Electromagnetic immunity

The BT-500 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-500 should assure that it is used in such an environment.

Immunity test

discharge (ESD)

IEC 61000-4-2

transient/burst

IEC 61000-4-4

IEC 61000-4-5

interruptions and voltage variations on power supply input lines

IEC 61000-4-11

Test level

Contact ±2㎸, ±4㎸, ±8㎸, ±15㎸ Air

230 V~ 50 ㎐ Power supply line, ±2 ㎸ AC, 100 ㎑ PRR

supply line, ±0.5㎸,±1㎸ L1 to L2

240 V~ 50 ㎐ Power supply line

0 % UT for 0.5 cycle

0% UT for 1 cycle

50 ㎐ : 70 % UT for 25 cycles 60 ㎐ : 70 % UT for 30 cycles

50 ㎐ : 0 % UT for 250 cycles 60 ㎐ : 0 % UT for 300 cycles

Compliance level

Contact ±2㎸, ±4㎸, ±8㎸, ±15㎸

Air

230 V~ 50 ㎐ Power supply line, ± 2 ㎸ AC, 100 ㎑ PRR

±2 kV line(s) to earth

240 V~ 50 ㎐ Power supply line

0 % UT for 0.5cycle

0% UT for 1 cycle

50 ㎐ : 70 % UT for 25 cycles 60 ㎐ : 70 % UT for 30 cycles

50 ㎐ : 0 % UT for 250 cycles 60 ㎐ : 0 % UT for 300 cycles

guidance

or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

that of a typical commercial or hospital environment.

that of a typical commercial or hospital environment. If the user of the BT-500 infant incubator requires continued operation during power mains interruptions, it is recommended that the BT-500 infant incubator be powered from an uninterruptible power supply.

(50 Hz and 60 Hz) magnetic field

IEC 61000-4-8

NOTE Uт is the a.c. mains voltage prior to application of the test level.

should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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IEC 60601 test

level

Compliance

level

Electromagnetic environment

- guidance

Conducted RF

230 V~ 50 ㎐

Portable mobile RF communications

following symbol :

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)

Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3 V/m.

Immunity test

IEC 61000-4-6

Radiated RF IEC 61000-4-3

Power supply line

3 Vrms, 150㎑ -80㎒

6 Vrms in ISM Bands between

0.15㎒ and 80 ㎒

3 V/m, 10 V/m 80 ㎒ to 2.7 G㎐ 80%, 1 ㎑ AM

RF Wireless Comm. (Refer to test report clause

1.15)

Power supply line

3 Vrms, 150㎑ -80㎒

6 Vrms in ISM Bands between

0.15㎒ and 80 ㎒

3 V/m, 10 V/m 80 ㎒ to 2.7 G㎐ 80%, 1 ㎑ AM

RF Wireless Comm. (Refer to test report clause

1.15)

equipment should be used no closer to any part of the BT-550, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

150㎑ -80㎒

80 ㎒ to 2.7 G㎐

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 determined by an electromagnetic site survey

should be less than the compliance level in each frequency range

Interference may occur in the vicinity of equipment marked with the

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 environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BT- BT-500 is used exceeds the applicable RF compliance level above, the BT-350 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-500.

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Product Name

Infant Incubator

Model Name

BT-500

Serial No.

Warranty Period

2 Years

Date of Purchase

Hospital:

Manufacture

Bistos Co., Ltd.

Product Warranty

Address:

Customer

Sales Agency

※ Thank you for purchasing BT-500. ※ 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.

Name:

Telephone:

Service Telephone and Fax. Numbers

Telephone: +82 31 750 0340

Fax: +82 31 750 0344

FL., A Bldg., Woolim Lions Valley 5-cha, 302,

Galmachi-ro, Jungwon-gu, Seongnam-si,

Telephone: + (32) 2. 732.59.54

Bistos Co., Ltd.

Gyeonggi-do, Korea

www.bistos.co.kr

bistos@bistos.co.kr

Obelis s.a

Bd. Général Wahis 53

1030 Brussels, BELGIUM

Fax.: + (32) 2.732.60.03

Bistos BT-500 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual