Bistos BT-550 User Manual

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BT-550 Operation Manual

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P/N : 550-ENG-OPM-EUR-R01

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

Information and descriptions contained in this manual are the property of Bistos Co., Ltd. and may not be copied, reproduced, disseminated, or distributed without express written permission from Bistos Co., Ltd.

Information furnished by Bistos Co., Ltd is believed to be accurate and reliable. However, no responsibility is assumed by Bistos for its use, or any infringements of patents or other rights of third parties that may result from its use. No license is granted by implication or otherwise under any patent or patent rights of Bistos Co., Ltd.

The information contained herein is subjects to change without notice.

Prepared by:

Bistos Co., Ltd.

FL., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea

Telephone: +82 31 750 0340 Fax: +82 31 750 0344

Revision R01 Mar,2018

Proprietary Material

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

Contents

0. Safety information ······················································································ 4

0.1 General precautions, warnings and cautions ···························································· 6

0.2 Shock hazards ············································································································· 9

0.3 General precautions on environment ······································································· 10

1. System basics ······························································································ 11

1.1 Indication for use ········································································································ 11

1.2 Operating principle ····································································································· 11

1.3 System configurations ································································································ 12

1.4 Product outlook ·········································································································· 14

1.5 Description of system components ············································································ 15

1.6 Understanding the display ························································································· 20

1.7 Buttons ······················································································································· 21

1.8 Alarm and warning indication ····················································································· 23

1.9 Essential performance ································································································ 25

2. Operation of BT-550····················································································· 26

2.1 Precautions ················································································································· 26

2.2 Assembling BT-550 ····································································································· 27

2.2.1 Repositioning the column ·················································································· 27

2.2.2 Installing the IV pole to column (option) ··························································· 30

2.2.3 Installing the plate for auxiliary equipment to column (option) ························ 31

2.3 Separating barriers ····································································································· 32

2.4 Tilting bed ··················································································································· 33

2.5 Skin temperature sensor ···························································································· 34

2.6 Prepare to use ············································································································· 35

2.7 Operation ···················································································································· 36

2.8 SpO2 Monitor(option) ······························································································· 39

3. Placing infant and moving BT-550 ································································ 46

3.1 Placing infant ·············································································································· 46

3.2 Move the BT-550 ········································································································ 46

3.2.1 Precautions ········································································································ 46

3.2.2 Stand caster lock ································································································· 47

4. Maintenance and cleaning ·········································································· 48

4.1 Service policy ·············································································································· 48

4.2 Maintenance ·············································································································· 48

4.3 Cleaning ······················································································································· 48

5. Trouble shooting ·························································································· 50

5.1 General ······················································································································· 50

5.2 Understanding alarms ······························································································· 50

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

6. Manufacturer’s declaration on EMC ·································································· 51

6.1 Electromagnetic emissions ····························································································· 51

6.2 Recommended separation distances between portable and mobile RF communications equipment and the BT-550 ···························································································· 52

6.3 Electromagnetic immunity ······························································································ 53

7. Technical specifications ···················································································· 55

Product Warranty ·································································································· 57

Figure 1-1: Front View ··············································································································· 14 Figure 1-2: Side view ················································································································· 14 Figure 1-3: System components ································································································ 15 Figure 1-4: Head ························································································································ 16 Figure 1-5: Column ···················································································································· 17 Figure 1-6: Bassinet ··················································································································· 18 Figure 1-7: Stand part ················································································································ 19 Figure 1-8: Display when SpO Figure 1-9: Display when SpO Figure 1-10: Buttons ·················································································································· 21 Figure 1-11: POWER Fail ············································································································· 23 Figure 1-12: Sensor Disable ········································································································ 23 Figure 1-13: S1 Tem p Erro r ········································································································· 23 Figure 1-14: S2 Tem p Error ········································································································ 23 Figure 1-15: Baby Check ············································································································· 23 Figure 1-16: Head Rotation ········································································································ 23 Figure 1-17: Masimo Check Alarm ····························································································· 24 Figure 1-18: Masimo Alarm Message ························································································· 24 Figure 2-1: Repositioning the column (1) ·················································································· 27 Figure 2-2: Repositioning the column (2) ·················································································· 28 Figure 2-3: Repositioning the column (3) ·················································································· 29 Figure 2-4: Installing IV pole ······································································································ 30 Figure 2-5: Installing plate for auxiliary equipment ··································································· 31 Figure 2-6: Separating barriers ·································································································· 32 Figure 2-7: Tilting handles ·········································································································· 33 Figure 2-8: Skin temperature sensor ·························································································· 34 Figure 2-9: Power cord ··············································································································· 35 Figure 2-10: Product logo and initial screen··············································································· 35 Figure 2-11: Caster locks ············································································································ 47

option not installed ·································································· 20

option installed ········································································· 20

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

WARNING

CAUTION

Used to identify safety information.

During the operation, do not disconnect any cable.

his symbol indicates the authorized representative in the European

0 Safety information

Before using BT-550 Infant warmer, read this entire manual and be fully understood the following safety information to prevent injury of patient and user.

Symbols Used

The following symbols identify all instructions that are important to safety. Failure to follow these instructions can lead to injury or damage to the infant warmer. When used in conjunction with the following words, the symbols indicate:

Can lead to serious injury or death.

Can lead to minor injury

The following symbols are placed on product, label, packaging and this manual in order to stand for the information about:

Be well-known this information thoroughly before using BT-550.

Indicate the warning for hot surface.

IPX0 IPX0 Non-protected against ingress of water with harmful effects.

IPX1

IPX2

IPX6

IPX1 Protected against the vertically dripping water

(Skin temperature sensor_2EA)

IPX2 Protected against the dripping water

(SpO2 sensor)

IPX6 Protected against the powerful jetting

(Foot switch_2EA)

Refer to operation manual. Read manual before placing the device.

Indicates the weight limit

This symbol indicates the manufacturer.

This symbol indicates the serial number of the device.

T Community of manufacturer.

This symbol indicates a type BF applied part.

This symbol indicates to keep the device dry.

This symbol indicates the device is fragile.

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

This symbol indicates the temperature limitation for operation, transport

This symbol indicates the humidity limitation for operation, transport and

This symbol indicates the compliance with the essential requirements and

This symbol indicates to not dispose the device together with

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

DO NOT

be RECYCLED in accordance with local regulations, contact your local

and storage.

storage.

This symbol indicates the packing material is recyclable.

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

unsorted municipal waste(for EU only). The solid bar symbol indicates that mains adapter is put on the market after 13 August 2005.

DISPOSAL

could be hazardous to human health and the environment. DISPOSE of this product as unsorted municipal waste. This product needs to

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

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

Thoroughly read and understand the manual prior to use of the BT-550. Failure

s directed by an appropriately

se of accessories other than those listed and approved for use with this

rtified accessories with the appropriate International

Medical electrical equipment needs special precautions regarding EMC and

The equipment shall not be used adjacent to other devices unless verification of

0.1 General precautions, warnings and cautions

• Examine the warmer and any accessories periodically to ensure that the cables, line cords and

instruments do not have visible evidence of damage that may affect patient safety or performance. The recommended inspection interval is once per week or less. Do not use the warmer if there is any visible sign of damage.

• Only the AC line cord supplied with the BT-550 is approved for use with the Unit.

• Do not attempt to service the BT-550 infant warmer. Only qualified service personnel by

Bistos Co. Ltd., should attempt any needed internal servicing.

• The BT-550 is not specified or intended for operation during the use of defibrillators or during

defibrillator discharge.

• The BT-550 is not specified or intended for operation in the presence of electrosurgical

equipment.

• The BT-550 is not specified or intended for operation in conjunction with any other type of

equipment except the specific devices that have been identified for use in this Operator’s Manual.

• Perform periodic safety testing to insure proper patient safety. This should include leakage

current measurement and insulation testing. The recommended testing interval is once per year.

• Do not operate the BT-550 infant warmer if it fails to pass the power on self-test procedure.

WARNING



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

 Infant warmer misuse may result in harm to an infant. Only properly trained

personnel should use the infant warmer a qualified attending physician aware of currently known risks and benefits.

 U

product may result in increased emissions or decreased immunity.

 Use only ce

Electrotechnical Commission (IEC) 60601 harmonized national standard.



needs to be installed and put into service according to the EMC information provided in this manual. In addition, portable and mobile RF communications equipment can affect medical electrical equipment.



BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

normal operation in the configuration in which it is to be used can be achieved.

could result in personal injury or

or use it

must be in direct contact with the skin to provide

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

and burn with great intensity in air enriched with oxygen. Personal injury or

To avoid overheating the infant due to direct radiation, do not position the

monitor shelf, always place the monitor in the center of the shelf, ensure that

 For proper operation of the infant warmer, use only skin temperature sensor

from Bistos Co. Ltd. Using other sensor equipment damage.

 Never place the skin temperature sensor under the infant’s body

rectally. Personal injury could occur.

 The skin temperature sensor

accurate measurement of the infant’s skin temperature. Failure to maintain direct skin contact can result in overheating. Routinely check the infant’s condition for correct sensor attachment, and feel the infant’s skin for signs of overheating.



equipment damage could occur.

 Keep matches, and all other sources of ignition, out of the room in which the

infant warmer is located. Textiles, oils, and other combustibles are easily ignited

equipment damage could occur.

 Small quantities of flammable agents, such as ethyl and alcohol, left on the

infant warmer may cause a fire in connection with oxygen. Personal injury or equipment damage could occur.

 A fire and explosion hazard exists when performing cleaning or maintenance

procedures in an oxygen-enriched environment.



infant warmer in direct sunlight or under other sources of radiant heat.

 To prevent accidental disconnection when adjust the height, ensure that all

patient leads, infusion lines, and ventilator tubing have sufficient excess length.

 For infant’s safety, do not leave the infant unattended. Personal injury could

occur.

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

warmer stand. Personal injury of equipment damage could occur.

 For optimum stability, always lock all stand wheels. Do not leave the device

unattended when parking on an incline. Failure to do so could result in personal injury or equipment damage.

 Prior to placing the infant in the infant warmer, pre-warm the BT-550 to the

temperature prescribed by the attending physician, or according to nursing protocol.

 Only one monitor shelf should be used per infant warmer. When using the

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

the monitor fits within the border of the shelf, and avoid stacking monitors on

manual and found to comply with all relevant safety and performance

person or organization who makes an unauthorized modification, or

550 yourself to avoid damage to the

equipment and unexpected electrical shock. Only qualified Bistos service

heck the rating of power source compatible with the input voltage rating of

materials such as watch and ring and touch only the

the shelf. Personal injury or equipment damage could occur.

 Attach the infant warmer to the stand using the bolts provided. Failure to do so

could result in the infant warmer separating from the stand if sufficiently tilted. Personal injury or equipment damage could occur.

 This product has been validated with the accessories and options listed in this

requirements applicable to the device. It is therefore the responsibility of that

incorporates an unapproved attachment to the device.

 An operator may only perform maintenance procedures specifically described

in this manual.

 Do not remove the covers of a BT-

engineer must repair or replace components.

 C

BT-550.

 The UART port is for debugging purposes only. It does not allow connections

with other devices.

 Take off the metallic

insulated plastic part of BT-550

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

Unplug the unit from its power source prior to cleaning or maintenance to prevent

ome chemical cleaning agents may be conductive and leave a residue that may

o not allow cleaning agents to

To ensure grounding reliability, plug the AC power cord only into a properly

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

The total power of all equipment connected to the convenience outlet strip on the

the electrical requirements shown on the rear of the stand.

uilding power source is compatible with the electrical

0.2 Shock hazards

WARNING



personal injury or equipment damage.

 S

permit a build-up of conductive dust or dirt. D contact electrical components and do not spray cleaning solutions onto any of these surfaces. Personal injury or equipment damage could occur.



grounded 3-wire hospital-grade or hospital-use outlet. Do not use extension cords. If any doubt exists as to the grounding connection, do not operate the equipment. Personal injury or equipment damage could occur.



Personal injury or equipment damage could occur.

 Do not touch the patient and signal input/output parts simultaneously

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

service documentation should service the unit.



stand must be within Otherwise, personal injury or equipment damage could occur.

 Make sure the b

specifications shown on the column of the stand and on the infant warmer. Failure to do so could result in personal injury or equipment damage.

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

BT-550 power cord directly to an AC wall socket when the BT-550 is mounted on a pedestal /stand. Always provide power to the BT-550 by using the power cord coming directly from the pedestal /stand.

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

Avoid placing in an area

Power off when the

0.3 General precautions on environment

Do not keep or operate the equipment under the environment listed below.

Avoid placing in an area exposed to moisture. Do not touch the equipment with wet hand.

where high variation of temperature exists. Operating temperature

ranges from 18 Operating humidity

ranges from 0 % ~ 95 %.

℃ ~ 30℃.

Avoid exposure to direct sunlight

Avoid in the vicinity of electric heater.

Avoid placing in an area where there is an excessive humidity rise or ventilation problem.

Avoid placing in an area where chemicals are stored or where there is in danger of gas leakage.

Do not disjoint or disassemble the device. Bistos Co., Ltd. does not have liability of it.

Avoid placing in an area where there is an excessive shock or vibration.

Avoid dust and especially metal material enter into the equipment

equipment is not fully ready to operate. Otherwise, the equipment could be damaged.

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

1 System basics

1.1 Intended use

The BT-550 Infant Warmer is intended to emit controlled, evenly distributed overhead heat to the body of premature infant and other newborns that cannot effectively regulate their body temperature. This device can be used before any treatment or operation of an infant. The device has two operating functions; the baby mode and the manual mode. In the baby mode, the temperature is controlled by the infant’s skin temperature. The infant’s skin temperature is compared to the temperature setting. If the measured skin temperature is lower than a temperature setting value, the warmer operates to increase the skin temperature of an infant. In the manual mode, the warmer operates for a predefined time.

The device has the option for weighing scale and SpO2 measuring functions. Weight and SpO2 of infant can be measured using the options. In the SpO2 measurement, the sensor is place at the end of a finger. By measuring the intensity of reflected light, depending on the concentration of dissolved oxygen in the blood determines the oxygen concentration.

1) Intended patient population

- Newborns, Premature infant, Low birth weight infant

- Age up to 3 months

- Weight up to 10 Kg

2) Intended user profile

- Nursing staff or physicians who is qualified personnel

- Basic experiences or knowledge on medical field, especially on obstetrics

- Trained or requested to read IFU before use

3) Environment of use

- Hospital (birthing center, delivery rooms), Neonatal intensive care unit (NICU)

- Requirements: Stable power source

1.2 Operating principle

The BT-550 infant warmer is electrically powered device with a radiant heating source intended to maintain the thermal balance of an infant by direct radiation of energy in the infrared region of the electromagnetic spectrum. The maximum irradiance level at any point on the mattress is 100% heater output, 28 ㎽/㎠±20% in the total infrared spectrum.

The following graph shows the emissivity data of infrared radiation used for the BT-550 Infant Warmer. It has the specific frequency band of 2 ~ 11㎛.

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

1.3 System configurations

Basic configuration of BT-550

• Main body with fixed height stand

• Mattress & Power cable

• 2 skin temperature sensor

Options of BT-550

• Motor-driven height adjustable stand (Lift stand)

• Intravenous(IV) pole

• IV Plate for auxiliary equipment

• Basket(Drawer)

• Basket partition

• Weighing scale

• Bed tilting mechanism

• SpO

• Extension for SpO2 sensor

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

Picture

Name

Description

Qty

Masimo

(Optional)

Fixed Stand

(Standard)

Mattress

(Standard)

Skin temperature

sensor (Standard)

AC power code

(Standard)

Masimo SpO2

sensor probe

(Optional)

Extension for

SpO2 sensor

Movable warmer cradle with wheels 1ea

Accommodate infant stably with bouncy mattress

1ea

Measures infant’s skin temperature 2ea

AC Power cord(AC Power cord for operating the equipment)

1ea

Measures infant’s SpO2 1ea

Extend sensor cable 1ea

Weighting Scale

(Optional)

Basket (Optional)

Basket Partition

(Optional)

IV-pole

(Optional)

IV plate

(Optional)

Lift Stand

(Optional)

Measures Infant’s weight 1ea

Store medical equipment and items which infant needs

1ea

Partition of Basket 1ea

IV hanger 1ea

Plate to place items which infant needs

Movable warmer cradle with wheels (VHA- Variable Height Adjustable)

1ea

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Bistos Co., Ltd.

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1.4 Product outlook

Basic configuration Configuration with full Options

Figure1-1: Front view

Figure1-2 : Side view

BT-550 Operation manual

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Bistos Co., Ltd.

2018.03

Equipped with infrared radiating light source and can be rotated

Supporting head part and equipped with electronic circuits to

he electronic circuits are composed with

side of column when the option has been selected.

Equipped with mattress and protective barriers to prevent the

easy access to infant patient.

1.5 Description of System components

①

②

③

④

Figure1-3: System components

Name Description

Head

up to 90° to left and right each and totally 180°.

operate BT-550 inside. T

Column

power supply part, display and user interface. The IV pole and plate for auxiliary equipment attached on the

Supporting the whole BT-550 system. Basic stand has fixed height. Height adjustable stand is available as option.

Stand

It has equipped with caster to move the BT-550 easily and can be fitted with drawer and bed tilting mechanism when options are selected.

patient from falling off the mattress. X-ray cassette tray is located

Bed

under the bed for X-ray procedure. Weighing scale plate can be placed beneath the mattress as option. Protective barriers can be opened or removed from the bed for

BT-550 Operation manual

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Bistos Co., Ltd.

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Examination

lamp

Ventilation

hole

Figure1-4: Head

①

②

③

④

Name Description

Alarm light Flashing red light in alarm status

Heat source

Composed with heating element, reflecting plate and protection guard to prevent touch the heating element

Provide added illumination of the mattress area

To ventilate the heated air around the heating element

BT-550 Operation manual

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Bistos Co., Ltd.

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WARNING

The maximum permitted load of IV pole is 5 kg. Do not hang heavy object on

place heavy object on the plate.

Figure1-5: Column

① IV Pole ②

Display LCD

③ B

uttons

④

Power switch

⑤ C

onnector for SpO2 sensor and weighing scale

⑥

Connector for Skin temperature sensor

⑦ P

late for auxiliary equipment (IV Plate)

⑧

Speaker



the pole.

 The maximum permitted load of plate for auxiliary equipment is 11 kg. Do not

BT-550 Operation manual

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Bistos Co., Ltd.

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WARNING

Do not place heavy objects on the X-ray cassette tray to prevent the device

heavy object on the tray.

Mattress ② X-ray cassette tray

①

Bed tilting mechanism ④ Tilting handle

③

Protective barriers ⑥ Weighing scale

⑤

Figure1-6 : Bassinet



falling down.

 Do not place any object under the bed while taking the X-ray radiation.

 Do not place infant on the X-ray cassette tray directly.

 Do not move the infant warmer while X-ray cassette tray expelled.

 The maximum permitted load of X-ray cassette tray is 1.5 kg. Do not place

BT-550 Operation manual

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Bistos Co., Ltd.

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WARNING

Do not place any items taller than the caster diameter of device to prevent any

the drawer.

Foot switch ② Drawer

①

AC power socket inlet ④ Caster

③

Figure 1-7: Stand part (Height adjustable stand)



disturbance of stability of stand and damage to the device

 Keep vacant surrounding stand about 30 cm.

 When adjusting the height of stand, place one hand on the infant warmer to

keep the balance of operator.

 Be sure that auxiliary equipment or items are removed from the moving path

when adjusting the height of stand. Before adjusting the height, secure the safe of infant and other connections.

 The maximum permitted load of drawer is 10 kg. Do not place heavy object in

BT-550 Operation manual

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Bistos Co., Ltd.

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1.6 Understanding the display

Figure 1-8: Display when SpO2 option not installed

Figure 1-9: Display when SpO

option installed

① Measured temperature ② Set temperature

③ Selected operation mode ④ Alarm mute indicator

⑤ Examination lamp status indicator ⑥ Weight measured

⑦ APGAR timer ⑧ Current time

⑨ Heater power output indicator ⑩ Blood oxygen saturation, pulse rate

⑪ Photo plethysmograph and Signal IQ

(Signal Identification and Quality indicator)

BT-550 Operation manual

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Bistos Co., Ltd.

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Button for increment of temperature set value in

Button for decrement of temperature set value in Alarm mute button. Push the button makes the

Button for lamp control. Lamp brightness changed Button for set-up. Press this button to enter set-up

Button for APGAR Timer Start and Stop.

Figure1-10 Buttons

1.7 Buttons

Button Name Description

[MODE] Button for mode selection.

[UP]

baby mode and heater output in manual mode. And can be used to move cursor upward or change the set value in setting mode.

[DOWN]

baby mode and heater output in manual mode. And can be used to move cursor downward or change the set value in setting mode.

[ALARM

MUTE]

[LAMP]

audible alarm muted for about 5, 10, 15 minutes. The red LED lighted when alarm muted.

in Low  Medium  High  OFF sequence when press the button.

[ZERO] Button to set the scale to zero.

[SETUP]

[APGAR*]

*The APGAR timer provides tones at 1, 5 and 10 mins set intervals to prompt the assessment on infants nursed under the BT-550 infant warmer.

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[APGAR

RESET]

Skin

temperature

sensor

connectors

Power

switch

Button for APGAR Timer Reset.

S1 : The first sensor to be attached to the abdomen of infant (The heater power in baby mode is controlled by the temperature measure from S1.)

S2 : The second sensor to be attached to the foot or ear lobe of infant

A switch that serves to change between the on state and the off state.

BT-550 Operation manual

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Figure

Description

POWER Fail

in white and red and audio alarm stays for 10

Figure1-12 : Sensor Disable

Sensor Disable

Figure1-14 : S2 Temp Error

Skin Temp high & low (for S1 and S2 sensor)

High Temperature: Alarm activated when the Baby Check

In manual mode, the alarm activated after 12

15 minutes.

Figure1-16 : Head Rotation

Head Rotation

degree, the heater output reduced to 0% and

1.8 Alarm and warning indication

Figure1-11 : POWER Fail

Figure1-13 : S1 Temp Error

• When the supply power are interrupted the

‘POWER FAIL’ warning message are displayed

minutes

• Alarms are activated when skin temperature

sensor did not connect to S1 connector.

•

measured temperature is higher than set temperature value by 1.0

℃ in baby mode or

38 ℃ in manual mode.

• Low temperature: Alarm activated when the

measured temperature is lower than set temperature value by 1.0 ℃ in baby mode or 30 ℃ in manual mode.

Figure1-15 : Baby Check

•

minutes and the heater output reduced to 25 % after 15 minutes.

• In baby mode, the heater output set to

100 %, the alarm activated after 12 minutes and the heater output reduced to 25 % after

• When the head is rotated more than 20

alarm activated.

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Masimo Check Alarm

Alarm message

Situation

Open LEDs

LED opened

Shorted LEDs

LED shorted

Interference detected

Interference between

detector

Low SpO2

Measured SpO2 value is

setting

No cable

SpO2 cable was not connected

Sensor off patient

Sensor was not connected to the patient

Unrecognized sensor

The system cannot recognize the sensor

Bad sensor ID offset

Not supported sensor connected

Shorted detector

The detector diode shorted

High pulse rate

Measured pulse rate is

setting

Low pulse rate

Measured pulse rate is

setting

No adhesive sensor

Not supported adhesive sensor connected

No sensor connected

Too much ambient light Low perfusion

Perfusion index is low

Low signal IQ

Signal IQ® is low

Masimo board failure

Masimo board failure and failure code

Diagnostic failure

Diagnostic failure and failure code

PROCAL FAILURE

ProCal failure

message pop-up displayed.

The following operation of device considered as fall back mode (mode of

Baby check

• Alarm will be activated upon following

situations:

Figure1-17: Masimo Check Alarm

Figure 1-18 Masimo Alarm message

transmitting LED and

lower than low limit

higher than high limit

lower than low limit

CAUTION



FALL BACK Mode

operation (or state) into which the Physiological Closed Loop Control System) transitions when the PCLC (Physiological Closed Loop Controller) stops operating due to detection of a fault).

 Sensor disable 

Skin temperature high/Low



Head rotation



• To see the alarm situation pressing down

the [ALARM MUTE] button until the

BT-550 Operation manual

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Bistos Co., Ltd.

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1.9 Essential performance

1) Accuracy of baby mode operation

The temperature as measured by the skin temperature sensor shall not differ from the control temperature by more than 0.5 ℃,

2) Generation of visual and audible alarm

After steady temperature condition have been achieved, any sensed temperature deviation exceeding

±1°C compared with the control temperature shall cause an auditory and visual alarms to operate, and the infant radiant warmer heater shall off when the sensed temperature exceeds the control

temperature by 1℃.

BT-550 Operation manual

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Bistos Co., Ltd.

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CAUTION

2 Operation of BT-550

2.1 Precautions

 Use the BT-550 in the environment temperature 18 ~ 30 ℃ and humidity 0 ~

95%(non-condensing).

 Be sure the power cord securely connected.

 Do not connect several cords to one socket outlet.

 Place the device on the flat floor.

 Do not use the power cord which can cause the electromagnetic noise

 Avoid the impact on the device.

 Use the device in the place free from dust or flammable agent

 Be sure to lock the caster before use.

 The device shall be used only by appropriately trained personnel and under the

direction of qualified medical personnel who are familiar with currently known risks and benefits of infant warmer use.

 BT-550 should not be used adjacent to or stack with other equipment.

 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 when there is difficult to disconnect from the supply mains.

 To avoid overheating or underheating, observe the infant constantly and monitor

the temperature using the skin temperature sensor supplied with the equipment or other electronic thermometer. It is important to note that the skin temperature alarms are not functional during manual operation. Therefore, the operator should use baby mode whenever possible.

BT-550 Operation manual

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Bistos Co., Ltd.

2018.03

2.2 Assembling BT-550

2.2.1 Repositioning the column

Figure 2-1: Repositioning the Column (1)

1. Remove the package.

2. Remove the four M6X25 Hexagon head bolt (number ② in figure) from column (hold the

column securely to prevent declining) with 5 mm hexagon wrench enclosed.

3. Remove the six M4x8 machine screws (number ③ in figure) and detach the back cover

(number ④ in figure) from column.

BT-550 Operation manual

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Figure2-2: Repositioning the column (2)

1. Push up the column and align with the fixing hole as indicated in the figure with red arrow

2. Fix with four M6x15 bolts (number ② in figure) which removed above procedure. Hold

column tightly until bolting finished to prevent fall down.

3. Replace the back cover (number ④ in figure) and fix with six M4X8 (number ③ in figure)

which removed above procedure.

4. Detach the fixing bracket from device by loosening the M6x25 9number ⑤ in figure).

BT-550 Operation manual

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Figure2-3: Repositioning the column (3)

The assembling position is different for standard configuration and full option configuration. Be sure to fixing on the right position depending on the options.

BT-550 Operation manual

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2.2.2 Installing the IV pole to column (Option)

Figure2-4 : Installing IV pole

1. Put the lower damper (number ⑤ in figure) to the lower part of column rail.

2. Slip-in the two joint nuts (number ⑥ in figure) to the column rail above the lower damper.

3. Put the upper damper (number ③ in figure) to the upper part of column rail.

4. Fix the IV frame to column with two M6X15 (number ④ in figure) using enclosed hexagon 5

mm wrench.

5. Put the IV pole (number ① in figure) to IV frame and fix it with turning screw located in the

frame.

2.2.3 Installing the plate for auxiliary equipment to column (Option)

BT-550 Operation manual

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Figure2-5 : Installing plate for auxiliary equipment to column

1. Put the lower damper (number

2. Slip-in the two joint nuts (number

3. Put the upper damper (number

4. Fix the plate frame (number

using enclosed hexagon 5 mm wrench.

5. Fix the plate (number

① in figure) to plate flame with M5X15 hexagon head bolt using

enclosed hexagon 4 mm wrench.

2.3 Separating barriers

⑥ in figure) to the lower part of column rail.

⑤ in figure) to the column rail above the lower damper.

④ in figure) to the upper part of column rail.

② in figure) to column with two M6X15 (number 7 in figure)

BT-550 Operation manual

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WARNING

Do always for both ends together.

Keep the barrier latched always when possible.

Pull the barrier upward.

Decline the barrier backward and detach upper locking pin.

Pull the barrier upward again and detach lower locking pin.

Figure2-6 : Separating barriers



 Regularly inspect the latches and closing devices of barriers to prevent the

infant falling out.



2.4 Bed tilting mechanism

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Figure 2-7: Tilting handle

Do not press a bed with over pressure.

Do not turn the tilting handle with excessive force.

WARNING

Tilting of the mattress from its horizontal position relative to the infant warmer

an increase in infant temperature to dangerous levels.

The bed can tilted for 15°±2° to backward or forward

CAUTION



heater can affect the performance of the infant warmer.

 The accessories such as phototherapy or heated mattresses, or sunlight can cause

2.5 Skin temperature sensor

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2018.03

WARNING

Never try to move the device while the infant placed in the device.

the infant warmer.

• Before adhere the sensor to infant, hold the metallic part of sensor

end with fingers and check the temperature display relevant to body temperature.

• Attach the S1 sensor to the abdomen and S2 sensor (option) to the

foot or ear lobe of infant using adhesive tape.

• The temperature measurement automatically started when power

on the device if the sensor is connected.

• Sensor is reusable. After use clean and store according to the

instructions described in section 4 of this manual.

Figure 2-8

Skin temperature sensor



 The skin temperature sensor should be contacted to bare skin of infant for correct

measurement. Otherwise the temperature can increase to dangerous levels. Frequently check whether the sensor contacted correctly to infant’s skin and overheat.

 Do not pull the wire of sensor. Remove the sensor by detach the adhesive tape.

 Independent monitoring of the temperature of the infant by the operator is

essential. Monitor the temperature of infant regularly with auxiliary thermometer.

 The infant warmer cannot differentiate between an increase in core temperature

with a cold skin (fever) and a low core and skin temperature (hypothermia). Monitor the temperature of infant regularly with auxiliary thermometer.

 The rectal temperatures are not appropriate for controlling the heater output of

2.6 Prepare to use

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1. Connect the power cord to the power

2. Connect all cables and sensors to the

3. Turn on the power and check

5. When the power on, BT-550 start to

WARNING

Securely latch the power cord to prevent the power cord unintentionally detached

body in force. Check the shape, position and direction of connector.

Figure 2-9: Power cord

Figure 2-10: Product logo and initial screen

inlet connector of BT-550. In the basic configuration, the power inlet connector is located under the column. In the full option configuration, it is located behind the stand assay. Clip the power cord to prevent detached unintentionally.

relevant connectors. Be sure to connect the cables and sensors to the right connectors.

whether the product logo and initial screen is displayed.

4. After booting sequence finished, the

main screen will be displayed. Check whether all the relevant information are displayed

operate in ‘pre warm’ mode with

100% heater output (28

㎽/㎠±20%)

for five minutes. After then the heater output decrease to 60% for 10 minutes and further decrease to 25%.



from power inlet connector.

 Do not pull or push when connecting or disconnecting connector from or to main

2.7 Operation

BT-550 Operation manual

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Bistos Co., Ltd.

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Infant warmer can increase the patient’s insensible water loss. Keep the water

Use the infant warmer in the place where the air flow is slower than 0.3 m/s.

(0) Power On

When the power switch turned on, initial logo screen displayed.

(1) Measuring the skin temperature of infant

The BT-550 start to measure the skin temperature of infant as the power switched on. When the skin temperature sensor does not connected to the connector in baby mode, sensor disable message displayed and audible alarm activated.

(2) Mode selection

Baby Mode – Heater output controlled automatically by measured skin temperature

• Select Baby Mode by pressing [MODE] button.

• Set the desired temperature by pressing [INCREASE] or [DECREASE] button. The heater

output controlled according to the measured skin temperature of S1 skin temperature sensor.

• ‘Baby Check’ message will displayed and alarm activated after 12 minutes if the heater

output stay 100 % and the output will be decreased to 25 % after 3 minutes when no button operation detected.

Manual Mode – Heater output controlled manually

• Select Manual Mode by pressing [MODE] button.

• Set the desired heater output by pressing [INCREASE] or [DECREASE] button.

• ‘Baby Check’ message will displayed and alarm activated if the device stay in Manual

Mode more than 12 minutes and the power will be decreased to 25 % after 3 minutes when no button operation detected.

WARNING



balance of patient carefully.

 Do not place any objects in the infant warmer to prevent the objects getting hot.

The objects can disturb the transfer of heat to patient.

 Heater, lamp and adjacent areas are very hot. Do not touch these parts with bare

hand.

 Infant warmer does not adjust for patient temperature in Pre-warm Mode. The

mode shall be changed to Manual Mode or Baby mode immediately when the patient is placed on the device.

 The skin temperature of infant can be affected by environment such as strong air

flow, direct sunlight. It is always recommended to use infant warmer in Baby Mode as possible.



(3) Weighing scale(Option)

BT-550 Operation manual

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Parameters

Default value

Control temperature in Baby Mode

36 ℃

Heater output in Manual Mode

50 %

Temperature unit

Weight Unit

Alarm mute period

5 minutes

Alarm sound level

Max

Pulse rate beep volume

3 steps

SpO2 algorithm mode

Normal sensitivity

SpO2 alarm delay

0 second

Average time

2-4 seconds

SpO2 low limit

Pulse rate high limit

200

Pulse rate low limit

100

Scale calibration value

Disabled

Weighing scale is option. The infant warmer measures the weight of infant automatically when the weighing plate is connected to the infant warmer. Press [ZERO] button to set the scale to zero.

(4) SpO2 and pulse rate (Option)

The SpO2 option is disabled when delivered. The enable/disable of SpO2 option can be changed in Service Mode. Press the following buttons in sequence to enter Service Mode: [UP]  [DOWN]  [UP]  [DOWN]  [SETUP]  [APGAR]  [APGAR RESET]. Change the SpO Option from DIS to EN. Select [EXIT] using [UP] or [DOWN] button and press [SETUP] button.

The SpO

function only activated when the SpO2 module connected to BT-550. The

measurement is started when the sensor is attached to infant’s index finger or other part (such as toe, ear lobe etc.). Use site appropriate according to each sensor’s individual direction for use.

(5) APGAR Timer

Press [APGAR] button to start the APGAR timer. Indicating sound will be heard on 1 minute, 5 minutes and 10 minutes. Press [APGAR] button to mute the timer. To reset the timer, press [APGAR RESET] button.

(6) Examination lamp

You can control the brightness of examination lamp. Press the [LAMP] button to change the lamp brightness from OFF to low, mid and high. Press the [LAMP] button again to OFF the lamp.

(7) Setup

Below is the initial factory setting of parameters;

In Setup Mode following parameters can be changed.

℃

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Category

Parameter

Description

Selection

Time

To set the current time

AM/PM, Hour and minutes

Temp. Unit

To select the temperature unit

(Celsius)/ ℉(Fahrenheit)

Weight Unit

To select the weight unit

kg(kilogram)/lb(pound)

Default set

All parameters are reset to factory setting

Mute period

Alarm paused time

5/10/15 minutes

PR beep volume

Pulse rate volume sound

0 ~ 5 steps

SpO2 alarm delay

SpO2 alarm delay time setup

0/5/10/15 seconds

Alarm test

To check alarm work correctly. The audio and visual alarm

audible and visible status before operating.

Algorithm

SpO2 measuring algorithm

Normal sensitivity,

Detection)

Normal

This selection provides the best combination of sensitivity

for the majority of patients

Maximum

This selection should be reserved for the sickest patients,

continuous.

APOD®

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

(pediatric, combative, etc.)

FastSat®

Enable rapid tracking of

ON/OFF

automatically activated

Average

Set the time to average

2-4/4-6/8/10/12/14/16 seconds

SpO2 alarm limt L

SpO2 low alarm limit. Alarm activated when measured value are lower than this limit. Cannot be set below 85.

PR alarm limt

Pulse rate low and high alarm limit. Alarm activated when

10 lower from high limit setting.

System

Alarm

℃

can be generated by ON the alarm test in Setup mode. The operator should be test the alarm system normality of

SpO2

mode

sensitivity

(Adaptive Probe Off Detection)

selection

Maximum sensitivity, APOD(Adaptive Probe Off

and probe-off detection performance and is recommended

where obtaining a reading is most difficult. Maximum sensitivity is designed to interpret and display data for even the weakest of signals, and is recommended during procedures and when clinician and patient contact is

patients with low perfusion but has the best detection for probe-off conditions. This mode is useful for patients that are at particular risk of sensor becoming detached

arterial oxygen saturation changes

When the average time set to 2-4 or 4-6, the FastSat

H, L

measured value are lower or higher than this limit. High limit can be set to 50 -240 and low setting value should be more than 10 higher from low limit setting. Low limit can be set to 40-230 and high setting value should be less than

(8) Power Off

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WARNING

SpO2 monitor of BT-550 must be operated by qualified personnel only.

Measure the oximeter’s leakage current whenever an external device is connected

Turn the power off after using the device. When the device expected do not used for a while, then unplug the power cord from socket outlet.

2.8 SpO2 Monitor(option)

This symbol means that the Masimo product inside.

BT-550 uses the Masimo SpO2 oximetry to monitor the oxygen saturation in the blood. You can find the detailed Masimo product information below.

Patent information for Masimo product can be found at www.masimo.com/patents.htm.

“Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would, alone or in combination with this device, fall within the scope of one or more the patents relating to this device”



 Do not use the MS board pulse oximeter in the presence of flammable anesthetics

or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide.

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

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

pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis.

 A pulse oximeter should be considered an early warning device. As a trend

towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition.

 If an alarm condition (other than exceptions listed herein) occurs while the alarm

silence period is set to off, the only alarm indications will be visual displays and symbols related to the alarm condition.

 The MS board pulse oximeter is to be operated by qualifier personnel only. These

manual, accessory directions for use, all precautionary information, and specifications should be read before use.

 Do not remove the monitor cover except to replace the battery. An operator may

only perform maintenance procedures specifically described in this manual. Refer servicing to Masimo in repair of this equipment.



BT-550 Operation manual

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to the serial port. Leakage current must not exceed 100 microamperes.

CAUTION

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

The three-conducting plug must be inserted into a properly wired three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electrical code.

 Do not under any circumstances remove the grounding conductor from the power

plug.

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

be intact and undamaged.

 If there is any doubt about the integrity of the protective earth conductor

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

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

electrically isolated circuits.

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

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

possibility of patient entanglement or strangulation.

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

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.

 Carboxyhemoglobin may erroneously increase readings. The level of increase in

approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings.

 Do not use the MS board pulse oximeter or Masimo oximetry sensors during

magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns. The MS board pulse oximeter may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.

 Consult IEC 60601-1 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 patients, 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 situation table contained in IEC 60601-1.

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Bistos Co., Ltd.

2018.03

Do not autoclave or gas sterilize this oximeter.

may tend to read in the low to mid 80s. When elevated levels of MetHb



 Do not soak or immerse the monitor in any liquid.

 Use the cleaning solution sparingly. Excessive solution can flow into the monitor

and cause damage to internal components.

 Do not touch, press, or rub the display panels with abrasive cleaning compounds,

instruments, brushes, rough-surface materials, or bring them into contact with anything that could scratch the panel.

 Do not use petroleum-based or acetone solutions, or other harsh solvents, to

clean the oximeter. These substances attach the device’s materials and device failure can result.

 Check alarm limits each time the MS board pulse oximeter is used to ensure that

they are appropriate for the patient being monitored.

 If the accuracy of any measurement does not seem reasonable, first check the

patient’s vital signs by alternate means and the check the MS board pulse oximeter for proper functioning.

 Inaccurate measurements may be caused by

 Incorrect sensor application or use  Significant levels of dysfunctional hemoglobin. (e.g., carboxyhemoglobin or

methemoglobin)

 Intravascular dyes such as indocyanine green or methylene blue.  Interfering Substances: Dyes, Nail polish or any substance containing dyes,

that change usual blood pigmentation may cause erroneous readings.

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

pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG based arrhythmia analysis.

 Exposure to excessive illumination, such as surgical lamps (especially ones

with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material)

 Excessive patient movement  SpO

is empirically calibrated to functional arterial oxygen saturation in

healthy adult volunteers with normal levels of carboxyhemoglobin (COHb) and methemoglobin (MetHb). A pulse oximeter cannot measure elevated levels of COHb or MetHb. Increase in either COHb or MetHb will affect the accuracy of the SpO

 For increased COHb: COHb levels above normal tend to increase the

level of SpO of COHb that is present. High levels of COHb may occur with a seemingly normal SpO analysis (CO-Oximetry) of a blood sample should be performed.

 For increased MetHb: the SpO

up to approximately 10% to 15%. At higher levels of MetHb, the SpO

measurement.

. The level of increase is approximately equal to the amount

. When elevated levels of COHb are suspected, laboratory

may be decreased by levels of MetHb of

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Bistos Co., Ltd.

2018.03

are suspected, laboratory analysis (CO-Oximetry) of a blood sample

- The patient is in cardiac arrest or is in shock.

should be performed.

 Venous congestion may cause under reading of actual arterial oxygen

saturation. Therefore, assure proper venous outflow from monitored site. Sensor should not be below heart level (e.g. sensor on hand of a patient in a bed with arm dangling to the floor).

 Venous pulsation may cause erroneous low readings (e.g. tricuspid value

regurgitation).

 Patient suffers from abnormal pulse rhythm.  The pulsations from intra-aortic balloon support can be additive to the pulse

rate on the oximeter pulse rate display. Verify patient’s pulse rate against the ECG heart rate.

 Use only Masimo approved accessories.  Motion artifact man lead to inaccurate measurements.  Elevated levels of Total Bilirubin may lead to inaccurate SpO2 measurements.  With very low perfusion at the monitored site, the readings may read lower

than core arterial oxygen saturation.

 Do not expose the Pulse CO-Oximeter to excessive moisture such as direct

exposure to rain. Excessive moisture can cause the Pulse CO-Oximeter to perform inaccurately or fail.

 Do not immerse the sensor or patient cable in water or, solvents, or cleaning

solutions (The sensors and connectors are not waterproof).

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

catheter, or intravascular line.

 The MS board can be used during defibrillation, but the readings may be

inaccurate for a short time.

 Loss of pulse signal can occur in any of the following situation

- The sensor is too tight

- There is excessive illumination from light sources such as a surgical lamp, a

bilirubin lamp, or sunlight.

- A blood pressure cuff is inflated on the same extremity as the one with a

SpO2 sensor attached

- The patient has hypotension, severe vasoconstriction, severe anemia, or

hypothermia.

- There is arterial occlusion proximal to the sensor.

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).

BT-550 Operation manual

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Bistos Co., Ltd.

2018.03

- Operating Principles

The BT-550 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 variable and that fluctuating absorbance by venous blood is a major component of noise during the pulse.

The pulse oximeter of BT-550 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. 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 BT-550 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. BT-550 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 empirically derived equation are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia studies.

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

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Bistos Co., Ltd.

2018.03

WARNING

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 sought to determine the SpO

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

between 1% and 100% and generates an N’ value for each of these R-values. The S(660) and S(905) signals are processed with each possible N’ noise reference through an adaptive correlation canceler (ACC) which yields an output power for each possible value of R (i.e., each possible SpO

from 1% to

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

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

The DST plot has two peaks: the peak corresponding to the higher saturation is selected as the SpO value. This entire sequence is repeated once every two seconds on the most recent four seconds of raw data. The MS board SpO 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 not available, a qualified electrician must install one in accordance with the governing electrical code.

therefore corresponds to a running average of arterial hemoglobin

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Bistos Co., Ltd.

2018.03

Do not under any circumstances remove the grounding conductor from the power

be intact and undamaged.

WARNING

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

patient cable; use only the handle on the monitor.



plug.

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

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.



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

- 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.

BT-550 Operation manual

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Bistos Co., Ltd.

2018.03

WARNING

Pre-warm the infant before placing infant in the infant warmer under the direction

Do not leave an infant unattended under the infant warmer.

WARNING

Never move the infant warmer while an infant is placed.

The infant warmer should be carried by two persons.

3 Placing infant and moving BT-550

3.1 Placing infant

(1) Pre-warm infant warmer.

(2) Place the infant in the center of mattress.

(3) Attach the skin temperature sensor to the appropriate part such as abdomen with adhesive

tape.

(4) Select the operating mode and set the desired temperature or heater output according to the

selected mode.



of qualified medical personnel who are familiar with currently known risks and benefits of infant warmer use.



3.2 Move the BT-550

3.2.1 Precautions

(1) Check whether an infant placed in the infant warmer mattress.

(2) Disconnect all cables from stand and remove unused accessories.

(3) For the height adjustable stand, adjust the height to lowest position.

(4) Place the power cord on the device to protect.



 Push or pull to the direction along the longitudinal of stand to prevent

overbalancing.



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Figure 2-11: Caster locks

WARNING

Always keep the caster locked for safety. When the infant warmer placed on the inclined floor, do not leave the infant warmer unattended.

3.2.2 Stand caster lock

At least two casters should be locked

Caster unlocked

before using. To lock the caster, depress the caster lock. To unlock the caster, raise above the caster lock.

Caster locked



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2018.03

WARNING

Do not remove the covers of BT-550 yourself to avoid damage to the infant warmer

changed.

Do not use the conductive or flammable cleaning agent to avoid electric shock, fire

4 Maintenance and cleaning

4.1 Service policy

The repair of infant warmer should be performed qualified service personnel. Contact to Customer Service Department of Bistos when the device fault or malfunctioning.

4.2 Maintenance

It is recommended to have a safety inspection every year regularly for the safe use of BT-550. Refer to the service manual for the inspection items and method.



and unexpected electrical shock. Only qualified Bistos service engineer must repair or replace components.

 The life time of heater is about 5 000 hours. After this time the heater should be

4.3 Cleaning

Follow the instruction prior to clean the infant warmer.

 Turn off the BT-550 and detach the power cord.  Detach all accessories from BT-550.  Cool down the BT-550 for about 30 minutes.  Use a clean gauze pad or lint-free cloth, lightly moistened with a water or mild detergent, to

wipe the surface of BT-550.

WARNING



or explosion.

 Do not use spray type cleaning agent.

 Do not scrub the display with rough or sharp objects.

 Do not use steam to clean the infant warmer. Excessive steam can damage the

infant warmer.

 Avoid using alcohol and strong detergent to bassinet made of acrylic.

 Ensure no part of the warmer or accessories are immersed in any cleaning agents.

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Bistos Co., Ltd.

2018.03

4.3.1 Skin sensor

- Clean the sensors with alcohol, or detergent or soap solution.

- Apply the cleaning solution with a clean cloth or sponge, and dry all surfaces after cleaning with a clean soft cloth or paper towel.

CAUTION:

• Do not immerse, boil, autoclaves or gas sterilize the sensor.

• Avoid soaking in alcohols, strong detergents. Or highly alkaline solutions.

• Ensure the skin sensor is only removed from the controller by grasping the plug at the

front panel. Ensure excessive strain is not placed on the sensor lead either during use, cleaning or inspection

4.3.2 SpO

sensor

- Clean the sensor by wiping it with a 70% isopropyl alcohol pad or mild detergent.

- Dry the sensor and cable with a clean cloth or dry gauze pad.

CAUTION:

• Do not immerse the connector of YI cable in any liquid solution.

• Do not sterilize by irradiation, steam, autoclave, Gluteraldehyde (Cidex) or ethylene

oxide.

• Carefully read 2.8 SpO2 Monitor(option) for proper use, cleaning or inspection

4.3.3 Mattress

- Clean the mattress with an approved and correctly diluted disinfectant-detergent solution, ensuring the manufacturer’s directions for use of the cleaning agent are followed.

- Apply the cleaning solution with a clean cloth or sponge, and dry all surfaces after cleaning with a clean soft cloth or paper towel.

Do not autoclaves or gas sterilize the mattress.

CAUTION:

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2018.03

WARNING

Do not attempt to open the covers, disassemble or modify the infant warmer

service engineer must repair or replace the infant warmer or components.

The infant warmer does not turned on

Check the power cord securely connected

Measured values are not displayed

Check the sensor cable or extension cable Measured values are too high or low

Check the sensor correctly attached to

Alarm message

Alarm conditions

Power Fail

Power cord was not connected properly or power

Sensor Disable

Skin temperature sensor was not connected or

S1 (S2) Temp Low

Measured skin temperature is too low

S1 (S2) Temp High

Measured skin temperature is too high

Baby Check

Stay in the Manual Mode more than 12 minutes

Head Rotation Masimo check Alarm

Refer to the table on page 18

5 Trouble shooting

5.1 General



except the qualified person. It may cause safety hazard. Only the qualified Bistos

Please check before contact to Customer Service Department of Bistos for following cases

to power consent

correctly connected to appropriate connector.

5.2 Understanding alarm

The following alarms are displayed on the conditions of

does not supplied

measured temperature is too low

Check the sensor properly operating after connecting the sensor.

patient.

For the weight, check the heavy objects are placed while zero set or measuring.

Heater output remains 100 % in Baby Mode more than 12 minutes

The head on infant warmer rotated more than 20°

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2018.03

The BT-550 is suitable for use in all

6 Manufacturer’s declaration on EMC

BT-550 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-550 and should be kept at least 1 m away from the equipment.

6.1 Electromagnetic emissions

The BT-550 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-550 should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

The BT-550 uses RF energy only for its internal

RF emissions CISPR 11

Group 1

function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage fluctuations / flicker emissions IEC 61000-3-3

Class A

Complies

establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

Warning: This BT-550 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-550 or shielding the location.

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2018.03

The BT-550 is intended for use in an electromagnetic environment in which radiated RF

550 can help prevent

550 as recommended

Separation distance according to frequency of transmitter

0.01

0.1

100

For transmitters rated at a maximum output power not listed above, the recommended

maximum output power rating of the

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

6.2 Recommended separation distances between portable and mobile RF communications equipment and the BT-550

disturbances are controlled. The customer or the user of the BTelectromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BTbelow, according to the maximum output power of the communications equipment.

Rated maximum

[m]

output power of

transmitter

[W]

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

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

separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is 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.

affected by absorption and reflection from structures, objects and people.

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Bistos Co., Ltd.

2018.03

The BT-550 is intended for use in the electromagnetic environment specified below.

IEC 60601

Electromagnetic

Electrostatic

±6 kV Contact

Floors should be wood,

Electrical fast

±2 kV for power

Mains power quality should

Surge

±1 kV line(s) to

Mains power quality should

Voltage dips, short

< 5 % Uт

Mains power quality should

Power frequency

3 A/m

Power frequency magnetic

6.3 Electromagnetic immunity

The customer or the user of the BT-550 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

±8 kV air

supply lines ±1 kV for input/output lines

line(s) ±2 kV line(s) to earth

(> 95 % dip in Uт) for 0.5cycle

40 % Uт (60 % dip in Uт ) for 5 cycle

70 % Uт (30 % dip in Uт) for 25 cycle

<5 % Uт (> 95 % dip in Uт ) for 5 s

Compliance level

±8 kV air

supply lines ±1 kV for input/output lines

line(s) ±2 kV line(s) to earth

(> 95 % dip in Uт) for 0.5cycle

40 % Uт (60 % dip in Uт ) for 5 cycle

70 % Uт (30 % dip in Uт) for 25 cycle

<5 % Uт (> 95 % dip in Uт ) for 5 s

environment -guidance

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

be that of a typical commercial or hospital environment.

be that of a typical commercial or hospital environment. If the user of the BT-550 image intensifier requires continued operation during power mains interruptions, it is recommended that the BT-550 image intensifier 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.

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

BT-550 Operation manual

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Bistos Co., Ltd.

2018.03

Compliance

level

Electromagnetic environment -

guidance

Portable mobile RF communications

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

mobile radios, amateur radio, AM and FM radio broadcast and TV

environment due to fixed RF transmitters, an electromagnetic site survey should be

observed to verify normal

operation. If abnormal performance is observed, additional measures may be necessary, such

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

The BT-550 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-550 should assure that it is used in such an environment.

Immunity test IEC 60601 test level

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

IEC 60601-2-21

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

10 V/m

3 Vrms

3 V/m

10 V/m

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

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey,

should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol :

NOTE 1) At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and reflection from structures, objects and people.

telephones and land broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic

considered. If the measured field strength in the location in which the BT-550 is used exceeds the applicable RF compliance level above, the BT-550 should be

as re-orienting or relocating the BT-550.

BT-550 Operation manual

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Bistos Co., Ltd.

2018.03

Functional Characteristics

Temperature

Infrared Heater

Operation Mode

Manual Control

0 ~ 100%, 20levels

Skin Display Range

26 ~ 42°C ±0.3°C

Output Power

600W

Skin Control Range

34 ~ 38°C (in Baby Mode)

Life Time

5,000hrs Type

7" TFT Color LCD

Setting Range

0sec ~ 59min 59sec

Alarm

6 Events Alarms

Indicating Beep

1, 5, 10min

Examination Lamp

Function

LED

40W(10W x 4ea)

Microprocessor Controlled

Brightness Control

3levels

Rotation of Head

90° (Left, Light both Directions)

Illumination

> 7,000lx

Tripod Water Level

Power

PC Interface

Input

AC 100/240, 50/60Hz

RS232C

Consumption

750VA

Standard Configuration (Fixed height stand)

Skin Temperature Sensor

2ea

Mattress Quick guide

1ea 1ea

Power Cord

1ea

Operation manual

1ea

Options

Weight limit or Angle

Options

Weight limit or Angle

Lifting Stand

IV Pole

Approx. 5 kg

IV Plate

Approx. 11 kg

Weighing Scale

0 ~ 10.0 kg, ±50g

Basket(Drawer)

Approx. 10 kg

Masimo SpO2

Basket Partition

Extension for SpO2

Tilting Bed

±15°

Dimension

Weight

Standard

1,027(W)x690(D)x1,890(H)mm

Standard

83 Kg

Fixed stand Lifting stand

725(H) mm 615 ~ 815(H)mm

Full option

98 kg Mattress

495(W) x 810(D) x 27(H)mm

with Safe Working Load

Approx. 124kg

Packing

1,150(W)X750(D)x1,550(H)mm

Packing

126Kg(Full Option)

Operation environment

Storage environment

Temperature

18 ~ 30°C (64.4 ~ 86°F)

Temperature

–10 ~ 60°C (14 ~ 140°F)

Air pressure

70~106 kPa

Air pressure

70~106 kPa

Standard

7. Technical specifications

(Each of tolerance

range is ± 20%)

Display APGAR

(Visual & Sound)

-Prewarm (100% @28 ㎽/㎠)

Range

-Baby mode (100% @ 28 ㎽/㎠)

-Manual (100% @ 8 ㎽/㎠)

Physical Characteristics

Humidity 0 ~ 95% non-condensing Humidity 0 ~ 95% non-condensing

IEC60601-1, IEC60601-1-2 IEC60601-2-21

BT-550 Operation manual

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Bistos Co., Ltd.

2018.03

Masimo Oximeter

Saturation (% SpO2)

Perfusion

1% - 100%

0.02% - 20%

Saturation (% SpO2) – During no

Neonate

0% - 69%, unspecified

Saturation (% SpO2) – During motion

Neonate

0% - 69%, unspecified

Pulse Rate (bpm) – During no motion conditions

25 to 240, ± 3 digits

Pulse Rate (bpm) – During motion conditions

25 to 240, ± 5 digits

Saturation (% SpO2) Pulse Rate (bpm)

1% 1 Low Perfusion Performance

> 0.02% Pulse Amplitude

and % Transmission > 5%

Saturation (%SpO2) ± 2 digits Pulse Rate ± 3 digits

Carboxyhemoglobin may erroneously increase readings. The level of increase in

erroneous readings.

Voltage Input Range

Rechargeable battery

90 – 240 VAC, 47 – 63 Hz

Up to 7 hours battery life

Fuses

0.75A, Time Delay, 250 V

Chassis Leakage current Less than 1.0 Ω

Operating temperature

-1,000ft to 18,000ft(-304m to 5,486m)

Microprocessor controlled

Trend data output of SpO2, pulse rate

Adjustable volume audible pulse: OFF and 33% to 100% in 4 steps

System failure and battery low alarms

Dimensions

Weight

8.2” x 6.0” x 3.0”

2.1 lbs, 32 oz (0.928 kg)

Averaging mode Sensitivity

2,4,8,10,12,14 and 16 seconds Normal, APOD, and MAX

Range

Accuracy

Resolution

Interfering Substances

Power

Pulse Rate (bpm)

motion conditions

conditions

25 - 240

70% - 100%, ± 3 digits

approximately equal to the amount of carboxyhemoglobin present. Dyes or any substances containing dyes that change usual arterial pigmentation may cause

Max. AC power consumption

20 VA

Isolation

Environment

Circuitry

Auto indicators

Physical characteristics

Ground resistance

Less than 100 ㎂mp

41℉ to +104℉(5℃ to + 40℃)

Storage temperature Relative humidity Operating altitude

-40℉ to +158℉(-40℃ to + 70℃) 5% to 95% non-condensing 500 mbar to 1060 mbar pressure

Automatic self-test of oximeter when power on

Automatic setting of default parameters Automatic alarm messages

Adjustable volume audible alarm tone: levels and 33% to 300% in 4 steps Alarm silence (120 seconds); all mute (continuous silence) Smart tone ON/OFF: excessive motion and low perfusion conditions pulse tones Pulse rate out-of-limits alarm SpO2 level out-of-limits alarm Sensor conditions alarms

(20.8cm x 15.2cm x 7.6cm)

Modes

BT-550 Operation manual

P/N : 550-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2018.03

Product Name

Infant Warmer

Model Name

BT-550

Serial No.

Warranty Period

2 Years

Date of Purchase

Hospital:

Sales Agency

Manufacture

Bistos Co., Ltd.

Product Warranty

Address:

Customer

※ Thank you for purchasing BT-550. ※ 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-550 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual