Bistos BT-500 Operation Manual
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Bistos BT-500 Operation Manual

Infant incubator
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BT-500
Infant Incubator Operation Manual
Keep this manual for future reference
P/N : 500-ENG-OPM-EUR-R14
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 14
Dec., 2020
Copyright © Bistos Co., Ltd. 2018. All rights reserved.

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Summary of Contents for Bistos BT-500

  • Page 1 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 2: Table Of Contents

    3.3.2 Cable connection 3.3.3 Sensor module connection 3.4 Placement of infant 3.5 Movement and installation 4 Operation 4.1 System start-up 4.2 LED 4.3 Key and knob operation 4.3.1 Key 4.3.2 Knob 4.4 Displays P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 3 8 Troubleshooting 8.1 General checking 8.2 Error message checking 9 Declaration on EMC 9.1 Electromagnetic emissions 9.2 Recomended separation distances between portable and mobile RF communications equipment and the device 9.3 Electromagnetic immunity Warranty P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 4: Safety

    Do not use the incubator if there is any visible sign of damage.  Only the AC line cord supplied with the BT-500 is approved for use with the Unit.  Do not attempt to service the BT-500 incubator. Only qualified service personnel by Bistos Co., Ltd.
  • Page 5  verification of normal operation in the configuration in which it is to be used can be achieved. Use only Bistos recommended fuel cells for proper operation. Failure to do so could result  in personal injury or equipment damage.
  • Page 6 Use distilled water only (<10 ppm total dissolved solids). The use of sterile water is not  acceptable. Equipment damage could occur. For proper operation of the incubator, use only skin temperature probes from Bistos Co.  Ltd. Using other probes could result in personal injury or equipment damage.
  • Page 7 If airflow passages are not kept clear of obstructions, such as blankets and stuffed  animals, during clinical usage, patient safety and incubator performance may be P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 8 VH that there is sufficient clearance between the incubator and stand assembly. Do not raise or lower the unit while installing or removing medical gas tanks from the tank holder assembly. Failure P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 9 Inaccurate measurements may be caused by incorrect application or use.  Inaccurate measurements may be caused by significant levels of dysfunctional  hemoglobin (HbCO or MetHb). Inaccurate measurements may be caused by intravascular dyes such as indocyanine green  or methylene blue. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 10 When the measured value is not completed, then the “---“ is displayed.  During long time continuous monitoring of a patient, check the position of SpO2 sensor  once every 2 hours, and move properly when the skin changes or every four hours. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 11 AC wall socket when the incubator is mounted on a pedestal /stand. Always provide power to the incubator by using the power cord coming directly from the pedestal /stand. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 12: General Precautions On Environment

    Power off when the Do not disjoint or equipment is not fully disassemble the equipment. installed. BISTOS Co., Ltd. does not Otherwise, the equipment take responsibility of it. could be damaged. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd.

  • Page 13: Symbols

    Symbol Description Used to identify safety information. Be well-known this information thoroughly before using BT-500. During the operation, do not disconnect any cable. Indicate the warning for hot surface. Type BF Applied part Refer to operation manual. Read manual before placing the device.

  • Page 14: Introduction

    The device is intended to use in a hospital. 2.3 Intended Use BT-500 is an infant incubator for non-invasively measuring and showing graphically humidity, air temperature, skin temperature, O Module, weight and SpO .

  • Page 15: Essential Performance

    If the module is equipped, alarm for low SpO2, high and low pulse rate occurs based on the set limit. WARNING Do not use the skin temperature control on babies who are in shock or who have high temperatures P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 16: Accessaries And Options

    IV hanger. (Optional) AC power code AC Power cord(AC Power cord for operating the (Standard) equipment) External LCD Displays measured values from the control and Monitor video of infant inside the hood. (Optional) P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 17 * The built-in air filter requires periodic replacement to maintain clean air. Periodic replacement of the pads according to the maintenance schedule is recommended. **Oxygen control module is also available as an optional component. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 18: Front View

    BT-500 Operation Manual 2.7 Appearance of BT-500 2.7.1 Front View Control Shell ① Hood ② Sensor module ③ Moving Stand ④ Basket ⑤ IV pole ⑥ IV plate ⑦ External monitor ⑧ Figure 2-1. Front view 2.7.2 Front View Detail Console box ①...

  • Page 19: Side View

    Figure 2-5. Right view 2.8 Description of each part BT-500 is composed with several parts. The control shell is the part which controls the entire device. To measure the infant’s environment, the sensor module is needed. The hood is used to protect an infant from the external environment and maintain the internal environment of hood to best condition.

  • Page 20: Control Shell

    For more information about how to clean, see "Chapter 6 cleanliness and maintenance” 2.8.2 Hood The hood of BT-500 is an acrylic material. There is Access door in the front, rear and both sides of hood. Figure 2-8. Hood front view & Access door / side function WARNING To prevent accidental disconnection, secure all access panel latches.

  • Page 21: Mattress Tray

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

  • Page 22: Install And Connection

    BT-500 Operation Manual 3 Install and Connection Attention to follow direction for installing BT-500.  Use this device in 20~30 ℃ of environmental temperature and 0~90 % of humidity.  Check the connection of the AC power cord and then use this cord, ...

  • Page 23: Plate

    Ringer pole (1ea) ① IV ringer pipe, 25.4mm (1ea) ② Machine screw M3x12, pin head (4ea) ③ IV LCD frame (1ea) ④ Lock washer M6 (2ea) ⑤ Screw M6x25 (2ea), ⑥ hexagon wrench 5mm P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 24: Air Filter Assembly

    Connect 110V or 220V AC power cord to power, and connect the code to the power input terminal one side of the body below the BT-500 body. At that time, make sure latch the cord by using the locking device for prevent of unexpected separation.

  • Page 25: Cable Connection

    4) Close the access door and ensure the pawl latches are fully engaged. WARNING Prior to placing the infant in the incubator, pre-warm the incubator to the  temperature prescribed by the attending physician, or according to nursing protocol. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 26 Make sure that items placed on the monitor shelf are properly secured. Failure to do so could result in personal injury or equipment damage. To place the BT-500 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.

  • Page 27: Operation

    Operation Manual 4 Operation 4.1 System Start-up 1) Turn on the power switch in the bottom left of the BT-500 front. 2) Then check the following logo is displayed in the main LCD. 3) Make sure the system check screen is being output.

  • Page 28: Led

    To unlock the key locking function, you should use [Keylock] key. When you push [Keylock] key, LED is off. Then you can go into mode setting and setting of control parameters. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 29: Key And Knob Operation

    +0.1 ℃ or +1 % Rotate CW -0.1 ℃ or -1 % Rotate CCW Menu Push Select options / Finish selecting options Rotate(CW/CCW) Shift options and change setting value Table 4-3. Use of Knob 4.4 Displays P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 30 BT-500 Operation Manual BT-500 provides the one display screen and the one dynamic Menu window together. Figure 4-6 is the basic layout of BT-500. Figure 4-6. Main operation display Figure 4-7. Basic screen of Main display (O2 control available) ① Air temperature region This region displays the measured air temperature in the hood.
  • Page 31 Skin mode icon Control mode status : Skin mode Humidity mode icon Control mode status: Humidity mode Trend icon Trend indication O2 icon O2 indication SpO2 icon SpO2 indication PR icon Pulse rate indication P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 32: Temperature Measurement And Control

     Measurement: Measurement of air temperature and skin temperature are starting at the same time of BT-500 power on. In case of skin temperature, especially, metal part of skin temperature sensor probe must be attached to the infant’s abdomen. ...

  • Page 33: Humidity Measurement And Control

    2 should be removed. 4.6 Humidity Measurement and Control  Measurement: Humidity measurement starts at the same time when BT-500 is powered on.  Setting and Control: The measured value is displayed on humidity region in upper middle of screen and the setting value is displayed on setting region in upper right of screen with sky-blue.

  • Page 34: Weighing Scale Measurement

    4.8 Weighing Scale Measurement  Measurement: Weighing measurement starts at the same time when BT-500 is powered on. Measured data continuously displayed on lower part of screen in white Kg or pound unit according to set record. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd.

  • Page 35: Menu Function

    And you can set PR Beep volume level. There are 5 different volume levels. All setting values for alarm condition do not be changed by any interrupt such as power on and off. ③ Trend P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 36 This mode is recommended during procedures and when clinician and patient contact is continuous. This mode is the least sensitive in picking up a reading on patients APOD with low perfusion but has the best detection for prove-off P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 37 The range of 30 to 290 can be selectable. ⑥ Help BT-500 provide the simple information about the equipment. The information is as follow:  parts of full set BT-500  main control panel and main display  how to use and change mode and parameters P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd.

  • Page 38: Pulse Oximeter

    3. Arterio-venous shunting is highly variables and that fluctuating absorbance by venous blood is a major component of noise during the pulse. The pulse oximeter of BT-500 as well as traditional pulse oximetry determines SpO by passing red and P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd.
  • Page 39 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 SpO = 97%: P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 40 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 P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 41: External Monitor

    Operation Manual 4.12 External Monitor BT-500 uses external 7” Color TFT LCD monitor that displays measured values from the control and video of infant inside the hood. Cam mode, Graph mode and Massimo mode are shown as below. (1) Cam Mode...

  • Page 42: Shut Down

    Display when the event occurred. If no failure, it would be blanked. Each description about error codes is explained in Section 8. 4.13 Shut down To ensure safe terminating operation of BT-500, follow as below. 1) Turn off the Power switch to power down the incubator. 2) Turn off the main power source. 4.14...

  • Page 43: Alarms

    According to each alarm condition, alarm messages are displayed in the pop-up window on the center of the screen. And the alarm light at the sensor module can be flashed and an audio alarm sounds. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 44: Alarm Information

    Sensor module not in High place that can measure the temp. and humidity position condition inside of the hood). There is a problem with air humidity measurement Humidity sensor failure High sensor in the hood P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...
  • Page 45 39.5 ℃ ±0.5 ℃ in override mode. Low Humidity High Measured value is lower than setting value over 5%p. Additional alarm: This alarm for optional configurations is activated when it exceed the control range. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 46: Alarm Self-Test

    Note: A fully charged battery should supply the power failure alarm for approximately 30 minutes. If the alarm is tested for the full 10 minutes, BT-500 must be run at least 3 hours to recharge the battery before it is used to the patient. Total recharge time is 5 hours when the main power switch is on.

  • Page 47: Hood

    Keep the external surface clean and free of dust, dirt, and residual liquids. Clean with a damp cloth using mild soap and water or hospital approved, nonabrasive disinfectants. WARNING Turn off the BT-500 and unplug the BT-500 from the AC power source and  detach all accessories before cleaning. Do not immerse the unit in water or allow liquids to enter the case.

  • Page 48: Water Tank

    Keep the external surface clean and free of dust, dirt, and residual liquids. Clean with a damp cloth using mild soap and water or hospital approved, nonabrasive disinfectants. WARNING Turn off the BT-500 and unplug the BT-500 from the AC power source. Do not  immerse the unit in water or allow liquids to enter the case.

  • Page 49: Regular Inspection

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

  • Page 50: Disposal Of The Device

    When disposing of the BT-500, adhere to all applicable laws regarding recycling. If you are not able to dispose the BT-500 or you need a help for disposing the BT-500, please contact us. In the case of there are no appropriate ways to dispose, we will pick up the BT-500 for you.
  • Page 51 8mm, 9.5mm, 11mm, 13mm (Use only oxygen hose) Weighing scale: measurement of weight of the infant Measurement range 0.000 Kg ~10.000 Kg Accuracy ± 50 g Pulse rate(PR): measurement of pulse rate of the infant P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 52: Troubleshooting

    High (All) Measured sound pressure level 73 dBA A-weighted background level 48 dBA 8 Troubleshooting 8.1 General Checking When the following problems are happened, before contact the head office, please check following measures. P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 53: Error Message Checking

    If the unit has trouble, check the possible cause in sequence from above. 8.2 Error Message Checking If the BT-500 has some problem for operation, it display alarm messages as below. Alarm messages on Main Display Alarm...
  • Page 54 IR Current level 0080 Digital ground 0100 Positive Preamp voltage 0200 Preamp 0400 Positive Detector voltage 0800 Negative Detector voltage 1000 LED current 2000 Analog ground 4000 LED drive voltage 8000 Sensor ID P/N : 500-ENG-OPM-EUR-R14 Bistos Co., Ltd. 2020.12...

  • Page 55: Declaration On Emc

    EMC information provided in this user manual. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect the BT-500 and should be kept at least 1 m away from the equipment.

  • Page 56: Recomended Separation Distances Between Portable And Mobile Rf

    9.3 Electromagnetic immunity The BT-500 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-500 should assure that it is used in such an environment. IEC 60601 Electromagnetic environment -...
  • Page 57 Power supply line Power supply line voltage variations hospital environment. If the on power supply user of the BT-500 infant 0 % UT for 0.5 cycle 0 % UT for 0.5cycle input lines incubator requires continued operation during power mains...
  • Page 58 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BT- BT-500 is used exceeds the applicable RF compliance level above, the BT-350 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the BT-500.
  • Page 59 Sales Agency Manufacture Bistos Co., Ltd. ※ Thank you for purchasing BT-500. ※ This product is manufactured and passed through strict quality control and inspection. ※ Compensation standard concerning repair, replacement, refund of the product complies with “Framework Act on Consumers” noticed by Fair Trade Commission of Republic of Korea.

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