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• Page 1
  BT-400 Neonatal Phototherapy unit Operation Manual BT-400 Keep this manual for future reference P/N: 400-ENG-OPM-EUR-R09…
• Page 2
  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.

• Page 3: Table Of Contents

  BT-400 Operation Manual Table of Contents Section 1. Safety Information ——————- 1.1 Instructions for the Safe Operation and Use of BT-400 —————- 1.2 General Safety Information——————————— 1.3 General precaution on environment ———————— 1.4 Meaning of Symbols ———————————————— 1.5 Button symbols ———————— Section 2.

• Page 4: Section 1. Safety Information

  Do not touch the equipment with wet hand. There is a risk of electrical shock.  Only the AC cord supplied with the BT-400 is approved for use with the Unit.  Do not leave the power cable in the place where people or cargo passes through frequently.

• Page 5: General Safety Information

  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: Be informed that it may cause serious injury or death to the…

• Page 6
  Section 6 of this manual. Caution! 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. Caution! When attaching light to any floor stand, other than Bistos Roll Stand, confirm weight capacity of stand.

• Page 7: General Precaution On Environment

  BT-400 Operation Manual 1.3 General precaution on environment Do not keep or operate the equipment under the environment listed below. Avoid placing in an area exposed to Avoid exposure to moisture. Do not touch direct sunlight the equipment with wet hand.

• Page 8: Meaning Of Symbols

  Always protect the Infant’s eyes with eye patches or equivalent. — IEC 60878 This symbol indicates that BT-400 can overbalance when in any transport position on a plane inclined at an angle of 10° from the horizontal plane. Never step on surface of device.

• Page 9: Section 2. Product Description

  BT-400 Operation Manual 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.

• Page 10: Contraindication

  BT-400 Operation Manual This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) range of spectrum, so there is no concern about UV exposure to infant.

• Page 11: Appearance Of Bt-400

  BT-400 Operation Manual 2.6 Appearance of BT-400 The BT-400 phototherapy system includes the components shown in the following figure. 2.6.1 Description of Each Part of BT-400 Fig1. Main body and Roll Stand ① Light Source: The light can be adjusted both horizontally and vertically on the roll stand assembly to desiring angle.

• Page 12
  BT-400 Operation Manual 2.6.2 Description of Display and Control part of BT-400 Fig1. Display and control part ① LCD: Display the status information. ② Power button: Power ON/OFF. ③ Operating button : Time Setting and intensity of LED lights Control P/N: 400-ENG-OPM-EUR-R09 Bistos Co., Ltd.

• Page 13: Section 3. Installation And Connection

  To install the BT-400 in desired place, you should lock the two casters on the stand. To lock a caster, lower the stopper on the caster to the locking position. To unlock a caster, raise the stopper.

• Page 14: Power Connection

  Disconnect electrical power: Always switch off the power and disconnect the power cord when cleaning the light. Only the AC cord supplied with the BT-400 is approved for use with the unit. Do not connect the power cord with wet hands.

• Page 15: Section 4. Operation

  BT-400 Operation Manual Section 4 Operation 4.1 Operating Method for Control part 4.1.1 Display Item Phototherapy ① Baby Icon ② Mode Information ③ Operating Information ④ Setting Time ⑤ Remaining Time ⑥ Operating Time ⑦ Operating Status ⑧ LED Driving Time 4.1.2 Icons…

• Page 16
  BT-400 Operation Manual 4.1.3 Operating Mode Mode Meaning Continuous Mode LED status is ongoing until the user stops the device. Timer Mode LED operating is stopped automatically after setting time. 4.1.4 Operating Method 1. Power ON /OFF 1) Turn on or off the power by pressing button.

• Page 17: Operating Method For Light Source

  Caution! Please note that the set air temperature of incubator or heater output of infant radiant warmer or heated mattress may be reduced when BT-400 is used in combination with one of these therapy devices. Caution! Please note that the infant’s body temperature may be increased a bit when BT- 400 is used in combination with the warming therapy devices.

• Page 18: Essential Performance

  BT-400 Operation Manual Shield infant’s eye with protective eye shields designed for use during phototherapy. 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.

• Page 19: Section 5. Troubleshooting

  Troubleshooting Warning! Disconnect power cord before opening the light for repair. Warning! Do not attempt to service the BT-400. Only qualified service personnel by Bistos Co., Ltd. should attempt any needed internal servicing refer to service manual 400-EN- SVM. Problem…

• Page 20: Section 6. Cleaning And Maintenance

  When disposing of the BT-400, adhere to all applicable laws regarding recycling. If you are not able to dispose the BT-400 or you need a help for disposing the BT-400, please contact us. In case there are no appropriate ways to dispose, we will pick up the BT-400 for you.

• Page 21: Section 7. Specifications

  BT-400 Operation Manual Section 7 Specifications Functional Characteristics Light Source Function Type Blue LED (8ea) Uniform Distribution Intensity Peak Between Intensity Wavelength Low : 25 ~ 35µW/cm²/nm 450 ~ 475nm (at 40cm) Variation in ±10% (over 6hrs) High : 35 ~ 55µW/cm²/nm…

• Page 22: Section 8. Manufacturer’s Declaration On Emc

  Section 8 Manufacturer’s Declaration on EMC The BT-400 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-400 should assure that it is used in such an environment. 8.1 Disposal of the BT-400…

• Page 23
  BT-400 Operation Manual 8.2 Electromagnetic immunity IEC 60601 Electromagnetic Immunity test Compliance level environment -guidance Test level ±6 kV Contact ±6 kV Contact Electrostatic Floors should be wood, discharge (ESD) concrete or ceramic tile. If ±8 kV air ±8 kV air…
• Page 24
  BT-400 Operation Manual 8.3 Electromagnetic immunity Compliance Electromagnetic environment Immunity test IEC 60601 test level level — guidance Portable mobile RF communications equipment should be used no closer to any part of the BT-410, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
• Page 25
  8.4 Recommended separation distances between portable and mobile RF communications equipment and the BT-400 The BT-400 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the BT-400 can help prevent…

• Page 26: Product Guarantee

  Sales Agency Manufacture Bistos Co., Ltd ※ Thank you for purchasing BT-400. ※ 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.

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