BT-550
Operation Manual
Keep this manual for future reference
P/N : 550-ENG-OPM-EUR-R01
BT-550 Operation manual |
1 |
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Proprietary Material
Information and descriptions contained in this manual are the property of Bistos Co., Ltd. and may not be copied, reproduced, disseminated, or distributed without express written permission from Bistos Co., Ltd.
Information furnished by Bistos Co., Ltd is believed to be accurate and reliable. However, no responsibility is assumed by Bistos for its use, or any infringements of patents or other rights of third parties that may result from its use. No license is granted by implication or otherwise under any patent or patent rights of Bistos Co., Ltd.
The information contained herein is subjects to change without notice.
Prepared by:
Bistos Co., Ltd.
7th FL., A Bldg., Woolim Lions Valley 5-cha, 302,
Galmachi-ro, Jungwon-gu, Seongnam-si,
Gyeonggi-do, Korea
Telephone: +82 31 750 0340
Fax: +82 31 750 0344
Revision R01
Mar,2018
Printed in Korea
Copyright © Bistos Corporation 2018. All rights reserved.
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
2 |
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Contents
0.Safety information ······················································································ 4
0.1General precautions, warnings and cautions ···························································· 6
0.2Shock hazards ············································································································· 9
0.3General precautions on environment ······································································· 10
1.System basics ······························································································ 11
1.1Indication for use ········································································································ 11
1.2Operating principle ····································································································· 11
1.3System configurations ································································································ 12
1.4Product outlook ·········································································································· 14
1.5Description of system components ············································································ 15
1.6Understanding the display ························································································· 20
1.7Buttons ······················································································································· 21
1.8Alarm and warning indication····················································································· 23
1.9Essential performance ································································································ 25
2.Operation of BT-550····················································································· 26
2.1Precautions ················································································································· 26
2.2Assembling BT-550 ····································································································· 27
2.2.1Repositioning the column ·················································································· 27
2.2.2Installing the IV pole to column (option) ··························································· 30
2.2.3Installing the plate for auxiliary equipment to column (option) ························ 31
2.3Separating barriers ····································································································· 32
2.4Tilting bed ··················································································································· 33
2.5Skin temperature sensor ···························································································· 34
2.6Prepare to use············································································································· 35
2.7Operation···················································································································· 36
2.8SpO2 Monitor(option) ······························································································· 39
3.Placing infant and moving BT-550 ································································ 46
3.1Placing infant ·············································································································· 46
3.2Move the BT-550 ········································································································ 46
3.2.1Precautions ········································································································ 46
3.2.2Stand caster lock ································································································· 47
4.Maintenance and cleaning ·········································································· 48
4.1Service policy ·············································································································· 48
4.2Maintenance ·············································································································· 48
4.3Cleaning······················································································································· 48
5.Trouble shooting·························································································· 50
5.1General ······················································································································· 50
5.2Understanding alarms ······························································································· 50
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
3 |
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6.Manufacturer’s declaration on EMC ··································································51
6.1Electromagnetic emissions ····························································································· 51
6.2Recommended separation distances between portable and mobile RF communications equipment and the BT-550 ···························································································· 52
6.3Electromagnetic 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 SpO2 option not installed ··································································20 Figure 1-9: Display when SpO2 option installed ·········································································20 Figure 1-10: Buttons ··················································································································21 Figure 1-11: POWER Fail·············································································································23 Figure 1-12: Sensor Disable········································································································23 Figure 1-13: S1 Temp Error·········································································································23 Figure 1-14: S2 Temp 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
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
4 |
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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:
WARNING |
Can lead to serious injury or death. |
CAUTION |
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:
Used to identify safety information.
Be well-known this information thoroughly before using BT-550. During the operation, do not disconnect any cable.
IPX0
IPX1
IPX2
IPX6
Indicate the warning for hot surface.
IPX0 Non-protected against ingress of water with harmful effects.
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.
This symbol indicates the authorized representative in the European Community of manufacturer.
This symbol indicates a type BF applied part.
This symbol indicates to keep the device dry.
This symbol indicates the device is fragile.
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
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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.
This symbol indicates the compliance with the essential requirements and provisions of the Medical Device Directive 93/42/EEC as amended by 2007/47/EEC.
This symbol indicates to not dispose the device together with unsorted municipal waste(for EU only). The solid bar symbol indicates that mains adapter is put on the market after 13 August 2005.
DISPOSAL
In order to comply with EU Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE): This product may contain material which could be hazardous to human health and the environment. DO NOT DISPOSE of this product as unsorted municipal waste. This product needs to be RECYCLED in accordance with local regulations, contact your local authorities for more information. This product may be returnable to your distributor for recycling - contact the distributor for details.
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
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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
Thoroughly read and understand the manual prior to use of the BT-550. Failure 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 as directed by an appropriately qualified attending physician aware of currently known risks and benefits.
Use of accessories other than those listed and approved for use with this product may result in increased emissions or decreased immunity.
Use only certified accessories with the appropriate International Electrotechnical Commission (IEC) 60601 harmonized national standard.
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. In addition, portable and mobile RF communications equipment can affect medical electrical equipment.
The equipment shall not be used adjacent to other devices unless verification of
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
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normal operation in the configuration in which it is to be used can be achieved.
For proper operation of the infant warmer, use only skin temperature sensor from Bistos Co. Ltd. Using other sensor could result in personal injury or equipment damage.
Never place the skin temperature sensor under the infant’s body or use it rectally. Personal injury could occur.
The skin temperature sensor must be in direct contact with the skin to provide 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.
Do not use in the presence of flammable anesthetics. Personal injury or 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 and burn with great intensity in air enriched with oxygen. Personal injury or 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.
To avoid overheating the infant due to direct radiation, do not position the 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 monitor shelf, always place the monitor in the center of the shelf, ensure that
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
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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 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 manual and found to comply with all relevant safety and performance requirements applicable to the device. It is therefore the responsibility of that person or organization who makes an unauthorized modification, or incorporates an unapproved attachment to the device.
An operator may only perform maintenance procedures specifically described in this manual.
Do not remove the covers of a BT-550 yourself to avoid damage to the equipment and unexpected electrical shock. Only qualified Bistos service engineer must repair or replace components.
Check the rating of power source compatible with the input voltage rating of BT-550.
The UART port is for debugging purposes only. It does not allow connections with other devices.
Take off the metallic materials such as watch and ring and touch only the insulated plastic part of BT-550
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
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0.2 Shock hazards
WARNING
Unplug the unit from its power source prior to cleaning or maintenance to prevent personal injury or equipment damage.
Some chemical cleaning agents may be conductive and leave a residue that may permit a build-up of conductive dust or dirt. Do not allow cleaning agents to contact electrical components and do not spray cleaning solutions onto any of these surfaces. Personal injury or equipment damage could occur.
To ensure grounding reliability, plug the AC power cord only into a properly grounded 3-wire hospital-grade or hospital-use outlet. Do not use extension cords. If any doubt exists as to the grounding connection, do not operate the equipment. Personal injury or equipment damage could occur.
Do not expose the unit to excessive moisture that would allow for liquid pooling. Personal injury or equipment damage could occur.
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.
The total power of all equipment connected to the convenience outlet strip on the stand must be within the electrical requirements shown on the rear of the stand. Otherwise, personal injury or equipment damage could occur.
Make sure the building power source is compatible with the electrical specifications shown on the column of the stand and on the infant warmer. Failure to do so could result in personal injury or equipment damage.
To prevent equipment damage or accidental power disconnections, do not plug a BT-550 power cord directly to an AC wall socket when the BT-550 is mounted on a pedestal /stand. Always provide power to the BT-550 by using the power cord coming directly from the pedestal /stand.
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
10 |
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0.3 General precautions on environment
Do not keep or operate the equipment under the environment listed below.
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Avoid placing in an area |
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Avoid exposure to direct |
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exposed to moisture. Do |
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not touch the equipment |
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sunlight |
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with wet hand. |
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Avoid placing in an area |
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where high variation of |
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temperature exists. |
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Avoid in the vicinity of |
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Operating temperature |
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electric heater. |
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ranges from 18 ~ 30 . |
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Operating humidity |
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ranges from 0 % ~ 95 %. |
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Avoid placing in an area |
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Avoid placing in an area |
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where there is an |
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where there is an |
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excessive humidity rise |
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excessive shock or |
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or ventilation problem. |
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vibration. |
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Avoid placing in an area |
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Avoid dust and especially |
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where chemicals are |
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metal material enter into |
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stored or where there is |
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the equipment |
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in danger of gas leakage. |
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Do not disjoint or |
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Power off when the |
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equipment is not fully |
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disassemble the device. |
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ready to operate. |
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Bistos Co., Ltd. does not |
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Otherwise, the |
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have liability of it. |
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equipment could be |
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damaged. |
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
11 |
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1 System basics
1.1 Intended use
The BT-550 Infant Warmer is intended to emit controlled, evenly distributed overhead heat to the body of premature infant and other newborns that cannot effectively regulate their body temperature. This device can be used before any treatment or operation of an infant. The device has two operating functions; the baby mode and the manual mode. In the baby mode, the temperature is controlled by the infant’s skin temperature. The infant’s skin temperature is compared to the temperature setting. If the measured skin temperature is lower than a temperature setting value, the warmer operates to increase the skin temperature of an infant. In the manual mode, the warmer operates for a predefined time.
The device has the option for weighing scale and SpO2 measuring functions. Weight and SpO2 of infant can be measured using the options. In the SpO2 measurement, the sensor is place at the end of a finger. By measuring the intensity of reflected light, depending on the concentration of dissolved oxygen in the blood determines the oxygen concentration.
1)Intended patient population
-Newborns, Premature infant, Low birth weight infant
-Age up to 3 months
-Weight up to 10 Kg
2)Intended user profile
-Nursing staff or physicians who is qualified personnel
-Basic experiences or knowledge on medical field, especially on obstetrics
-Trained or requested to read IFU before use
3)Environment of use
-Hospital (birthing center, delivery rooms), Neonatal intensive care unit (NICU)
-Requirements: Stable power source
1.2 Operating principle
The BT-550 infant warmer is electrically powered device with a radiant heating source intended to maintain the thermal balance of an infant by direct radiation of energy in the infrared region of the electromagnetic spectrum. The maximum irradiance level at any point on the mattress is 100% heater output, 28 / ±20% in the total infrared spectrum.
The following graph shows the emissivity data of infrared radiation used for the BT-550 Infant Warmer. It has the specific frequency band of 2 ~ 11 .
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
12 |
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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
•SpO2
•Extension for SpO2 sensor
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
13 |
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Picture |
Name |
Description |
Qty |
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Fixed Stand |
Movable warmer cradle with wheels |
1ea |
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(Standard) |
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Mattress |
Accommodate infant stably with |
1ea |
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(Standard) |
bouncy mattress |
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Skin temperature |
Measures infant’s skin temperature |
2ea |
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sensor (Standard) |
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AC power code |
AC Power cord(AC Power cord for |
1ea |
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(Standard) |
operating the equipment) |
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Masimo SpO2 |
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sensor probe |
Measures infant’s SpO2 |
1ea |
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(Optional) |
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Masimo |
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Extension for |
Extend sensor cable |
1ea |
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SpO2 sensor |
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(Optional) |
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Weighting Scale |
Measures Infant’s weight |
1ea |
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(Optional) |
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Basket (Optional) |
Store medical equipment and items |
1ea |
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which infant needs |
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Basket Partition |
Partition of Basket |
1ea |
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(Optional) |
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IV-pole |
IV hanger |
1ea |
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(Optional) |
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IV plate |
Plate to place items which infant |
1ea |
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(Optional) |
needs |
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Lift Stand |
Movable warmer cradle with wheels |
1ea |
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(Optional) |
(VHAVariable Height Adjustable) |
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
14 |
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1.4 Product outlook
Basic configuration |
Configuration with full Options |
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Figure1-1: Front view |
Figure1-2 : Side view
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
15 |
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1.5 Description of System components
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Figure1-3: System components |
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Name |
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Description |
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Head |
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Equipped with infrared radiating light source and can be rotated |
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up to 90° to left and right each and totally 180°. |
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Supporting head part and equipped with electronic circuits to |
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operate BT-550 inside. The electronic circuits are composed with |
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Column |
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power supply part, display and user interface. |
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The IV pole and plate for auxiliary equipment attached on the |
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side of column when the option has been selected. |
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Supporting the whole BT-550 system. Basic stand has fixed |
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height. Height adjustable stand is available as option. |
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Stand |
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It has equipped with caster to move the BT-550 easily and can be |
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fitted with drawer and bed tilting mechanism when options are |
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selected. |
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Equipped with mattress and protective barriers to prevent the |
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patient from falling off the mattress. X-ray cassette tray is located |
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Bed |
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under the bed for X-ray procedure. Weighing scale plate can be |
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placed beneath the mattress as option. |
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Protective barriers can be opened or removed from the bed for |
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easy access to infant patient. |
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
16 |
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Figure1-4: Head
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Name |
Description |
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Alarm light |
Flashing red light in alarm status |
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Heat source |
Composed with heating element, reflecting plate and |
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protection guard to prevent touch the heating element |
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Examination |
Provide added illumination of the mattress area |
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lamp |
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Ventilation |
To ventilate the heated air around the heating element |
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hole |
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
BT-550 Operation manual |
17 |
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Figure1-5: Column
IV Pole
Display LCDButtons
Power switch
Connector for SpO2 sensor and weighing scaleConnector for Skin temperature sensor
Plate for auxiliary equipment (IV Plate)Speaker
WARNING
The maximum permitted load of IV pole is 5 kg. Do not hang heavy object on the pole.
The maximum permitted load of plate for auxiliary equipment is 11 kg. Do not place heavy object on the plate.
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P/N : 550-ENG-OPM-EUR-R01 |
Bistos Co., Ltd. |
2018.03 |
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