BT-400
Neonatal Phototherapy unit
Operation Manual
BT-400
Keep this manual for future reference
P/N: 400-ENG-OPM-EUR-R12
BT-400 Operation Manual |
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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.
Revision 12
August, 2019
Copyright © Bistos Co., Ltd. 2019. All rights reserved.
7th FL., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnamsi, Gyeonggi-do, Korea
Telephone: ++82 31 750 0340 |
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Fax: ++82 31 750 0344 |
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Printed in Korea |
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P/N: 400-ENG-OPM-EUR-R12 |
Bistos Co., Ltd. |
2019.08 |
BT-400 Operation Manual |
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Table of Contents |
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Section 1. Safety Information ----------------------------------------------------------- |
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1.1 |
Instructions for the Safe Operation and Use of BT-400 ----------------------------- |
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1.2 |
General Safety Information------------------------------------------------------------------ |
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1.3 |
General precaution on environment ------------------------------------------------------ |
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1.4 |
Meaning of Symbols ------------------------------------------------------------------------- |
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1.5 |
Button symbols -------------------------------------------------------------------------------- |
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Section 2. Product Description -------------------------------------------------------- |
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2.1 |
Intended Use ----------------------------------------------------------------------------------- |
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2.2 |
Physical Characteristics --------------------------------------------------------------------- |
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2.3 |
Operating Principle ------------------------------------------------------------------------- |
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2.4 |
Contraindication ----------------------------------------------------------------------------- |
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2.5 |
List of Accessories ---------------------------------------------------------------------------- |
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2.6 |
Appearance of BT-400 ----------------------------------------------------------------------- |
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Section 3. Installation and Connection ---------------------------------------------- |
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3.1 |
Installation -------------------------------------------------------------------------------------- |
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3.2 |
Power Connection ---------------------------------------------------------------------------- |
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Section 4. Operation ----------------------------------------------------------------------- |
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4.1 |
Operating Method for Control part -------------------------------------------------------- |
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4.2 |
Operating Method for Light Source ------------------------------------------------------- |
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4.3 |
Essential performance ----------------------------------------------------------------------- |
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Section 5. Troubleshooting ------------------------------------------------------------- |
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Section 6. Cleaning and Maintenance ----------------------------------------------- |
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6.1 |
Checking the Light Intensity----------------------------------------------------------------- |
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6.2 |
Cleaning------------------------------------------------------------------------------------------ |
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6.3 |
Disposal of the BT-400 ---------------------------------------------------------------------- |
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Section 7. Specifications ----------------------------------------------------------------- |
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Section 8. Manufacturer’s Declaration on EMC ---------------------------------- |
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Product Guarantee ------------------------------------------------------------------------- |
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Reference --------------------------------------------------------------------------------------------------- |
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P/N: 400-ENG-OPM-EUR-R12 |
Bistos Co., Ltd. |
2019.08 |
BT-400 Operation Manual |
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Section1
Safety Information
1.1 Instructions for the Safe Operation and Use of BT-400
BT-400 should be used only appropriately trained personnel and under the direction of qualified medical personnel familiar with currently known risks and benefits of infant phototherapy equipment use.
Do not attempt to service the BT-400. Only qualified service personnel by Bistos Co., Ltd. should attempt any needed internal servicing.
The BT-400 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.
Only the AC cord supplied with the BT-400 is approved for use with the Unit.
Monitoring the patient’s status while receiving phototherapy.
Due to photo effects, drugs and infusion liquids shall not be stored in the radiation area.
Do not touch the equipment with wet hand. There is a risk of electrical shock.
Do not leave the power cable in the place where people or cargo passes through frequently. There is a possibility that product or person trips on a cable.
While BT-400 is operating, use the eye shield or blindfold to protect eye when the light for the treatment illuminates other patients. And please check frequently that it has been worn properly.
When the equipment is about to exceed the useful life, it must be treated in accordance with relevant local laws and regulations or the hospital's rules and regulations.
Please unpack carefully to prevent damage. Before unpacking, carefully inspect the package. If any damage, please immediately contact the Bistos. Unpack in the correct way, carefully remove the monitor and accessories from the box and check with the packing list. Check if there is any mechanical damage. When the device is damaged, do not use it.
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P/N: 400-ENG-OPM-EUR-R12 |
Bistos Co., Ltd. |
2019.08 |
BT-400 Operation Manual |
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1.2 General Safety Information
Before administering phototherapy, read all section of this manual carefully.
Observe all precautions to ensure the safety of the patient and those near the instrument.
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 BT-400. When used in conjunction with the following words, the symbols indicate:
Warning
Caution
NOTE
Be informed that it may cause serious injury or death to the patient, property damage, and material losses
Be informed that it may cause no harm in life but lead to injury
Background information provided to clarify a particular step or procedure.
Warning!
CLASS I ME EQUIPMENT - To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
Warning!
BT-400 should not be used adjacent to or stack with other devices, unless verification of normal operation is completed.
Warning!
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. In addition, portable and mobile RF communications equipment can effect medical electrical equipment.
Warning!
Use of accessories other than those listed and approved for use with this product may result in increased emissions or decreased immunity.
Warning!
Eye protection: Do not look directly into the LEDs. During treatment, always protect the baby’s eye with patches or equivalent. Periodically and/or per your hospital protocol, verify that the baby’s eyes are protected and free of infection. Patients adjacent to the light may also need to be protected with eye patches or equivalent.
Warning!
Sensitive individuals may experience headache, nausea or mild vertigo if he/she stays too long in the irradiated area. Wearing glasses with yellow lenses can alleviate potential effects.
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P/N: 400-ENG-OPM-EUR-R12 |
Bistos Co., Ltd. |
2019.08 |
BT-400 Operation Manual |
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Warning!
Photoisomers: Bilirubin Photoisomers may cause toxic effects.
Warning!
Water balance: Some patients’ water balance may be disturbed.
Warning!
The unit can be tumbled at surface inclined more than 10 degrees.
Warning!
Photosensitive Drugs: The light generated can degrade photosensitive medications. Do not place or store any drugs near or in the illuminated area.
Warning!
Combustion gases: Do not use the light in the presence of gases that support combustion
(for example, oxygen, nitrous oxide, or other anesthetic agents).
Warning!
Disconnect electrical power: Always switch off the power and disconnect the power cord when cleaning the light.
Warning!
Even though she/he is an adult, the operator may experience some effects if she/he stays longer in the area irradiated by phototherapy
Warning!
Do not use flammable solution directly to the LED lamps. It may cause of degradation or damage on the LED lamps. For cleaning or maintenance, please follow the instruction described in Section 6 of this manual.
Warning!
Incorrect use of the LED, or the use of parts and accessories that are not manufactured of supplied by Bistos Co., Ltd can damage the light, and may cause injury to the patient and/or user.
Warning!
When attaching light to any floor stand, other than Bistos Roll Stand, confirm weight capacity of stand.
Warning!
Use of reflective foils may cause hazardous body temperatures when the type of phototherapy influences radiation.
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P/N: 400-ENG-OPM-EUR-R12 |
Bistos Co., Ltd. |
2019.08 |
BT-400 Operation Manual |
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Warning!
Blue light can hinder clinical observations by masking skin color changes, such as cyanosis.
Warning!
Infants who receive phototherapy and have an elevated direct-reacting or conjugated bilirubin level (cholestatic jaundice) may develop the bronze-baby syndrome.
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P/N: 400-ENG-OPM-EUR-R12 |
Bistos Co., Ltd. |
2019.08 |
BT-400 Operation Manual |
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1.3 General precaution on environment
Do not keep or operate the equipment under the environment listed below.
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Avoid placing in an |
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area exposed to |
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Avoid exposure to |
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moisture. Do not touch |
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direct sunlight |
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the equipment with |
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wet hand. |
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Avoid placing in an |
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area where there is a |
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high variation of |
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temperature. |
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Avoid in the vicinity |
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Operating temperature |
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of Electric heater |
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ranges from 10°C to |
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40°C. Operating |
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humidity ranges from |
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5% to 85%. |
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Avoid placing in an |
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Avoid placing in an |
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area where there is an |
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area where there is |
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excessive humidity rise |
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an excessive shock |
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or ventilation problem. |
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or vibration. |
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Avoid placing in an |
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Avoid dust and |
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area where chemicals |
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especially metal |
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are stored or where |
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material into the |
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there is in danger of |
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equipment. |
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gas leakage. |
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Do not disjoint or |
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Power off when the |
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disassemble the |
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equipment is not fully |
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equipment. |
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installed. |
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BISTOS Co., Ltd. does |
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Otherwise, the |
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not take responsibility |
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equipment could be |
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of it. |
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damaged. |
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P/N: 400-ENG-OPM-EUR-R12 |
Bistos Co., Ltd. |
2019.08 |
BT-400 Operation Manual |
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1.4 Meaning of Symbols
Symbol |
Meaning |
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The wrong operating and controlling the device might be cause |
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an undesirable consequence. |
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Refer to operation manual. Read manual before placing the |
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device. |
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Always protect the Infant’s eyes with eye patches or equivalent. |
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- IEC 60878 |
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This symbol indicates that BT-400 can overbalance when in any |
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transport position on a plane inclined at an angle of 10° from the |
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horizontal plane. |
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Never step on surface of device. |
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This symbol indicates the manufacture. |
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This symbol indicates manufacturer’s serial Number of device. |
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This symbol indicates the production date |
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This symbol indicates the Authorized Representative in |
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European Community of manufacturer. |
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This symbol indicates to keep the device dry. |
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This symbol indicates the correct upright position of package. |
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This symbol indicates the device is fragile. |
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This symbol indicates that the device contains an object which is |
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capable of being recycled. |
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This symbol indicates the temperature limitation for operation, |
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transport and storage |
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This symbol indicates the humidity limitation for operation, |
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transport and storage. |
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This symbol indicates the maximum number of identical |
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packages which may be stacked on one another. |
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This symbol indicates the maximum stacking load permitted on |
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the transport package. |
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The product is in conformity with European Medical Directive |
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93/42/EEC. This has been verified by a notified body. |
1.5 Button symbols
Symbol |
Meaning |
Power ON/OFF
Add an hour setting time in Timer mode
Remove a half-hour setting time in Timer mode
Stop the device and keep power ON
LED Control(ON, Intensity control, Pause)
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P/N: 400-ENG-OPM-EUR-R12 |
Bistos Co., Ltd. |
2019.08 |
BT-400 Operation Manual |
9 |
Section 2
Product Description
BT-400 Phototherapy Unit consists of two parts – Phototherapy light source (Main Body) and the Roll stand.
2.1 Intended Use
BT-400 Phototherapy light is intended for treatment of neonatal hyperbilirubinemia. The light can be used for infants in a bassinet, incubator, open bed, or radiant warmer.
The equipment is useful for an infant who is up to the age of three months and a weight less than 10 kg.
Note
Before use, read this entire manual carefully. There are safety considerations that should be read and understood before use
2.2 Physical Characteristics
BT-400 Phototherapy Unit is a floor-standing, mobile phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes(LEDs) to provide treatment for neonatal hyperbilirubinemia.
2.3Operating Principle
Light Source(Main Body)
The light consists of a lightweight plastic light enclose and power assembly. When used with the Roll Stand, the light can be adjusted both horizontally and vertically on the roll stand assembly.
The Phototherapy light can be used independently from the Roll Stand. In this case, joint assembly can be used to fix the light source.
Blue LEDs emit light in the range of 400 – 550 nm (peak wavelength 450 – 475 nm).
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P/N: 400-ENG-OPM-EUR-R12 |
Bistos Co., Ltd. |
2019.08 |
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