Bistos BT-350 Operator's Manual
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Bistos BT-350 Operator's Manual

Fetal monitor
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P/N : OPM(BT-350)EN, Rev.06

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Summary of Contents for Bistos BT-350

  • Page 1 P/N : OPM(BT-350)EN, Rev.06...
  • Page 2 Bistos Corporation. Information furnished by Bistos Corporation 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.

  • Page 3: Table Of Contents

    BT-350 Operator Manual Table of Contents 1. SAFETY ................4 1.1 Instructions for the Safe Operation and Use of the BT-350 Monitor ....4 1.2 Warnings ......................5 1.3 Cautions ......................5 1.4 Definitions of Symbols ..................8 2. INTRODUCTION ..............9 2.1 General ......................
  • Page 4 11.1 Self Test ....................... 38 11.2 Ultrasound Transducer Test ................. 38 11.3 UC(TOCO) Test ................... 39 11.4 Battery Disposal and Handling ..............39 11.5 Maintenance ....................39 11.6 Disposal of the BT-350 ................39 P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 5: Safety

    The recommended testing interval is once per year.  Do not operate the BT-350 monitor if it fails to pass the power on self- test procedure. WARNING: Be informed that it may cause serious injury or death to the patient, property damage, material losses against the “Warning”...

  • Page 6: Warnings

    This can cause the electric shock to the patient or operator. WARNING: SHOCK HAZARD — During upgrading the BT-350, do not use the BT-350 to the patient. This can cause the electric shock to the patient. Cautions...
  • Page 7 CAUTION: When the printer door is open, do not put the finger to the inside of BT-350. This can cause the finger wound. Also do not prick the inside of BT-350 when the printer door is open. This can cause the damage to the device or electric shock.
  • Page 8 Power off when Do not disjoint or the equipment is disassemble the equipment. not fully installed. BISTOS Co., Ltd. does not Otherwise, the take responsibility of it. equipment could be damaged. P/N : OPM(BT-350)EN www.bistis.co.kr...

  • Page 9: Definitions Of Symbols

    IPX8 (1 meter of water for over 40 minutes.) Operating instructions When disposing of some components (ex: internal NiMH battery), do not dispose as general wastes. Adhere to all applicable laws regarding recycling. P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 10: Introduction

    BT-350 Operator Manual Section Introduction General This chapter provides a general description of the BT-350 monitor including:  Brief Device Description  Product Features  Model Configurations Brief Device Description The BT-350 is a microprocessor-based fetal monitor, providing continuous monitoring, display, and recording of fetal heart rate (FHR) and uterine contraction (UC) for antepartum testing and monitoring.

  • Page 11: Options And Accessories

    (MW160, Bridge Power Corp.) Type / model : GP270AAHC GP Battery Technical data : 1.2V X 12ea, 2600mA (GP Batteries international Ltd.) Ultrasound transmission gel Ultrasound Gel (Sanipia, ECOSONIC) Table 2.1. BT-350 Accessories P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 12: Installation

    Dop1 Volume Up/Down Button ⑥ Dop2 Volume Up/Down Button ⑦ Alarm Sound On/Off Button ⑧ UC Reference Button ⑨ Mode Change Button ⑩ Printer On/Off Button ⑪ Speaker ⑫ Print Door Open Button P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 13: Description Of The Left Panel

    Power Adaptor Jack Connector ② Event Marker Connector ③ RS-232C Port Connector Description of the Right Panel ① ② ③ Fig. 3.3 Right Panel ① DOP1 Connector ② DOP2 Connector ③ UC Connector P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 14: Power On

    Operator Manual Power On When the user wants to turn BT-350 on, power adaptor is connected with power adaptor jack connector on left panel of BT-350 as shown in Figure 3.2 and power button is pressed. Patient Cables The ultrasound and TOCO transducer cable are connected to the right panel.

  • Page 15: Bt-350 Operation

    The monitor displays the startup screen during the power-on self-test. When the test is successfully completed the BT-350 displays the monitoring screen. If a malfunction is detected an error message displays and an error tone is sounded.

  • Page 16: Printer Paper Select

    FS151-90-80R-01 4.1.3 Printer Paper Select BT-350 is able to use two different types of papers. If you press control knob during self test, you can see paper select menu as shown Figure 4.2. Rotating control knob to choose paper type.

  • Page 17: Bt-350 Monitor Display Screen

    BT-350 Operator Manual BT-350 Monitor Display Screen Fig. 4.3 Main Monitoring Screen – Graph Mode Fig. 4.4 Main Monitoring Screen – Number Mode Press mode button [ ], then the relevant menu comes out as shown Figure 4.6. Rotate the control knob to select the ‘Number Mode” or “Graph Mode” item.

  • Page 18: Mode Frame

    AC Power Icon Indicates the unit is operating on AC power Indicates the battery charge status Battery Status Icon (Only when the BT-350 is operated by battery, this icon is displayed.) 4.2.1 Mode Frame The mode frame shows the current mode. There are monitoring mode, setup mode and trend mode.

  • Page 19: Heart Rate Graph Frame

    The battery icon also includes a scale indicating battery charge status. If AC power is disconnected, BT-350 uses the internal battery. Therefore in the case of AC power is disconnected, there is no problem to use BT-350.

  • Page 20: Patient Id

    DOP1 is not connected DOP1 OPEN while BT-350 is monitoring DOP2 is not connected DOP2 OPEN while BT-350 is monitoring Print door is opened while BT-350 is DOOR OPEN printing Paper is not loaded while BT-350 is No PAPER printing Battery’s charging level is low...

  • Page 21: Bt-350 Monitor Controls And Indicators

    BT-350 Operator Manual BT-350 Monitor Controls and Indicators There are seven buttons located on the front panel. The buttons are activated by pushed with the finger until an audible click is heard. CAUTION: Never use sharp or pointed objects to operate the front-panel switches.

  • Page 22: Data Saving

    In other cases the monitor will display the previous menu. Fig. 4.5 System setup menu Data Saving BT-350 has a data saving function. It can save up to 450 hours. It is able to save 3 hours for each patient, so it can accommodates 150 patients. 4.5.1...

  • Page 23: Trend Mode

    Button Function Searching for saved data in patient. Selecting Previous / Next Patient Searching for saved data in page. Selecting Previous / Next Page Tracing the saved graphic data P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 24: Recorder Operation

    (unfolding from the top of the pack) and the UC grid area right side. The recorder is now ready for use. CAUTION: When loading paper, the paper must be put side upward. Otherwise, the paper will not be printed. Fig. 5.1 Loading Paper P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 25: Operation

    In Fig.5.2, BT-350 prints many parameters such as FHR, FM, UC and the situation information. These parameters are displayed in LCD monitor. Especially to display FM Trace, BT-350 needs to be set FM graph is on. FHR Trace Situation...
  • Page 26 When the system (by algorithm and detect fetus Detection Mark automatic) movement(FM1) When the system (by algorithm and detect fetus Detection Mark automatic) movement(FM2) When the system AST Mark (by doctor) detect AST signal P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 27: Monitring Fetal Heart Rate

     Move all line cords and line-powered equipment at least 6 feet away from the BT-350. Check for extension cords running behind or under the bed and equipment in adjacent rooms. If the artifact heart rate indication ceases, the monitor may be used normally.
  • Page 28 Adjust the position of the transducer to find the fetal signal and to maximize its loudness. Secure the ultrasound transducer with the elastic belt. Make sure the transducer P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 29: Detail Procedure

    ⑩ Reposition the transducer as necessary until the clearest heart sound is heard. Three to five seconds after a clear heart beat sound is heard, the heart shaped indicator will flash synchronously with the sound. This indicates signal acceptance and recording. P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)
  • Page 30 ⑪ If not already activated, depress the [ ] pushbutton located on the front panel of the monitor. The recorder plots the FHR on the paper strip chart. Figure 6.2 Positioning of UC Probe P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 31: Uterine Contraction(Uc)

    (Tocotonometer) on the maternal abdomen and recording relative pressure changes. CAUTION: During the using BT-350, we do not intend that the cable of UC sensor contacts to the patient. To prevent that the cable contacts to the patient, please cover the patient’s abdomen section which have a possibility of contacting by the cable with cleaned gauze or fabric.

  • Page 32: Detail Procedure

    The recorder plots the UC on the paper strip chart. CAUTION: The probe belt may cause allergy or skin side effects to patient, if it is used so long time. P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 33: Event Marker

    The icon is downward pointing arrow. The monitor will display this downward pointing arrow in the information frame of the display. A strip chart printout of this event will also show this mark. P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 34: Cleaning And Disinfection

    Operator Manual Section Cleaning and Disinfection This chapter contains instructions for the care and cleaning of the BT-350 unit and its accessories. The BT-350 requires proper care and preventive maintenance. This ensures consistent operation and maintains the high level of performance necessary in monitoring procedures.

  • Page 35: Belts

    10 hrs at 25°C 45 min at 25°C Medical Products glutaraldehyde 14 days Maximum 14 days Maximum Reuse Contact Reuse Contact conditions based conditions based on on AOAC literature Sporicidal Activity references. Test only. P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 36: Specifications

    BT-350 Operator Manual Section Specifications BT-350 Monitor Specifications: Physical Characteristics Dimensions – 9.6 cm H x 32.6 cm W x 27.6 cm D Weight - approx. 5.5 kg Safety Complies with EN60601-1, EN60601-1-1, EN60601-2 Class I Equipment & Internal Powered Equipment...
  • Page 37 Open-door, slide-in Paper Detectors: Paper Out Loading Door Open Paper Speeds Normal: 1, 2, and 3 cm/min ±1% High-Speed: 10 cm/min (only in Trend mode) Paper Tracking Accuracy: ±1% (exclusive of paper accuracy) P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)
  • Page 38 @ Transducer Face = Ultrasonic Power / Area Corresponding to SATA entrance beam dimensions = 16.7 / 8.54865 = 1.95352482555725 ≒ 1.95 mW/cm @ Transducer Face = I @ Transducer Face / DF = 1.95 / SAPA SATA 0.444416 ≒ 4.4 mW/cm P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 39: Troubleshooting And Maintenance

    The tapping should be heard from the monitor. The transducer is operating properly if you can hear noise from the speaker. Remove from service if no noise is heard or until the proper cause is identified and repaired. P/N : OPM(BT-350)EN www.bistis.co.kr Rev. 06 (2013.04.12)

  • Page 40: Uc(Toco) Test

    When disposing of the BT-350, adhere to all applicable laws regarding recycling. If you are not able to dispose the BT-350 or you need a help for disposing the BT-350, please contact us. In the case of there are no appropriate ways to dispose, we will pick up the BT-350 for you.
  • Page 41 Telephone: Sales Agency Manufacture Bistos Co., Ltd ※ Thank you for purchasing BT-350. ※ This product is manufactured and passed through strict quality control and inspection. ※ Compensation standard concerning repair, replacement, refund of the product complies with “Consumer’s protection law”...
  • Page 42 Fl., A Bldg., Woolim Lions Valley 5-cha, 144-3, Sangdaewon-dong, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea www.bistos.co.kr bistos@bistos.co.kr Model Name: BT-350 EC Representative: Medical Econet Gmbh Im Erlengrund 20 / D-46149 Oberhausen / Germany Telephone: +49 (0)208 377 890-0 Fax: +49 (0)208 377 890 55 P/N : OPM(BT-350)EN www.bistis.co.kr...

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