Bistos BT-380 Operation Manual
  1. Manuals
  2. Brands
  3. Bistos Manuals
  4. Medical Equipment
  5. BT-380
  6. Operation manual

Bistos BT-380 Operation Manual

Fetal monitor
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
BT-380 Fetal monitor
Operation Manual
Keep this manual for future reference
P/N : 380-ENG-OPM-EUR-R00

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the BT-380 and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Bistos BT-380

Summary of Contents for Bistos BT-380

  • Page 1 BT-380 Fetal monitor Operation Manual Keep this manual for future reference P/N : 380-ENG-OPM-EUR-R00...

  • Page 2: Proprietary Material

    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.

  • Page 3: Table Of Contents

    BT-380 Operation manual Contents Safety information 0.1 General precautions, warnings and cautions 0.2 Shock hazards 0.3 Battery warnings 0.4 General precautions on environment System basics 1.1 Intended use 1.2 Operating principle 1.3 System configurations 1.4 Product outlook 1.5 Description of monitor 1.6 Understanding the display...
  • Page 4 21. Default parameter configuration 22. Common faults and maintenance 23. Manufacturer’s declaration on EMC 23.1 Electromagnetic emissions 23.2 Recommended separation distances between portable and mobile RF communications equipment and BT-380 …..…………42 23.3 Electromagnetic immunity Product Warranty P/N : 380-ENG-OPM-EUR-R00 Bistos Co., Ltd.

  • Page 5: Safety Information

    BT-380 Operation manual 0 Safety information Before using BT-380 Fetal monitor, 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 Fetal monitor.

  • Page 6: General Precautions, Warnings And Cautions

    Using the device to one patient at a time. WARNING • Thoroughly read and understand the manual prior to use of the BT-380. Failure to do so could result in personal injury or equipment damage. • The device is intended for clinical Fetal monitoring, and only trained and qualified doctors and nurses should use the device.
  • Page 7 An operator may only perform maintenance procedures specifically described in this manual. • Do not remove the covers of a BT-380 yourself to avoid damage to the equipment and unexpected electrical shock. Only qualified Bistos service engineer must repair or replace components.

  • Page 8: Shock Hazards

    Power off when the equipment is Do not disjoint or disassemble the not fully ready to operate. device. Bistos Co., Ltd. does not Otherwise, the equipment could be have liability of it. damaged.

  • Page 9: System Basics

    1.1 Intended use The BT-380 Fetal monitor is intended for non-invasive monitoring of fetal heart rates and uterine activity and is intended for monitoring of maternal ECG, blood oxygen saturation (SpO2), Temperature, and non-invasive blood pressure (NiBp) also. BT-380 is intended for generating alarms from fetal heart rate, for displaying, storing and recording patient data and related waveforms.
  • Page 10 BT-380 Operation manual Adult SpO2 sensor SpO2 sensor for adult (standard) extension cord Cord to connect the SpO2 sensor and main (Standard) body Adult NIBP cuff Measures NIBP for adult (standard) NIBP extension tube Tube to connect the NIBP cuff and main...

  • Page 11: Product Outlook

    BT-380 Operation manual 1.4 Product outlook Figure1-1: Front view Figure1-2 : Sider view Figure1-3 : Rear view 1.5 Description of monitor Figure1-4: Front view Name Description Indicates the priority of physiological alarm and technical alarms in different colors and flashing frequencies.
  • Page 12 BT-380 Operation manual Figure1-5: Right Side view Name Description Doppler1 DOP1/AST cable interface Doppler2 DOP2/AST cable interface UC cable interface Figure1-6: Left Side view Name Description NIBP NIBP cuff interface ECG cable interface SpO2 SpO2 cable interface TEMP Temperature probe interface...

  • Page 13: Understanding The Display

    BT-380 Operation manual 1.6 Understanding the display Figure 1-8: Standard display Name Description Patient Information Show patient Name and ID Show alarm status with corresponding alarm level color, physiological and technical alarms. In Alarm status DEOM mode, it displays “DEMO”.

  • Page 14: Essential Performance

    BT-380 Operation manual Change view mode from “Graphic mode” to “Numeric [View mode] mode” [NIBP] NIBP measurement start and stop [Main Menu] Shows all configurable setting menus 1.8 Essential performance This device Multi-parameter Fetal monitor provides not only FHR and UC parameter but also various maternal vital signs such as pulse rate, ECG, blood oxygen saturation, blood pressure and temperature by placing or inserting the various sensors to the appropriate site of patient.

  • Page 15: Preparing For Operation

    2.1.1 Unpack and check BT-380 Fetal monitor was inspected rigorously at the factory before delivery, in order to avoid being hit when transported, carried out careful packaging. Before unpacking, carefully inspect the package. If any damage, please immediately contact the Bistos.

  • Page 16: Basic Operations

    If any fatal error occurs during self-test, the system will alarm. If this case persists, please stop to using the monitor and contact the maintenance personnel or Bistos. Check all available monitor functions to ensure that the monitor operate properly.

  • Page 17: Operation Mode

    BT-380 Operation manual 3.3.4 Using menu Select the [Main Menu] smart key on the monitor to open the “Main Menu” mode as shown below. You can set-up the monitor. Figure 3-1: “Setting” menu The style of other menus is basically similar to the “Settings” mode as shown below. You can set-up the monitor screen if you need.

  • Page 18: Patient Information Management

    BT-380 Operation manual  Select “Factory Setup >>” →enter the password and confirm →“General” menu.  Select “Language”, and select the option as needed:  “English”: The interface language of the monitor is English.  “French”: The interface language of the monitor is French.

  • Page 19: Display Description

    BT-380 Operation manual  Select [View Mode] Smart Hotkey  Change view mode from “Graphic Mode” to “Numeric Mode” or vice versa. 5.2 Display description 5.2.1 Graphic mode Figure 5-1: Graphic mode The Graphic mode provides the parameter wave being monitored and the parameters displayed in the parameter area. This is the basic display of the monitor.

  • Page 20: Alarm Condition Priorities

    BT-380 Operation manual Strictly speaking, the prompt messages are not alarms. The monitor also will display some information associated with system status in addition to the physiological alarms and technical alarms, and generally such information do not involve the patient's vital signs. The prompt messages generally appear in the technical alarm area and parameters area.

  • Page 21: Alarm Setup

    BT-380 Operation manual  Alarm off 6.4.1 Alarm reset Select button, and you can temporarily turn off the alarm sound of currently occurring physiological alarms of the monitor, but the alarm information is still retained. For technical alarms, clear the alarm state, display alarm prompt information, the alarm state area displays the icon.

  • Page 22: Manual Event

    BT-380 Operation manual  “Off”: Turn off SpO alarm; icon is displayed in the parameter area, and the monitor won’t prompt the parameter alarm. Set the alarm limit In any cases, the alarm system only allows setting the values within the effective range of the system, and the upper alarm limit must be higher than the lower alarm limit.

  • Page 23: Detail Procedure

    BT-380 Operation manual  Adjust channel one speaker volume to the middle level. Adjust channel two speaker volume to zero if monitoring twins.  Apply ultrasound gel to the face of the transducer. Step 2: Acquiring the fetal heart signal ...

  • Page 24: Monitoring Sequence Overview

    BT-380 Operation manual 8.1 Monitoring sequence overview Step 1: Preparing the monitor  Turn the monitor on and verify that the normal monitoring screen appears on the display. Stop using the monitor if an error occurs.  Check whether the monitor is powered from the internal battery or AC power. If the monitor is powered from the internal battery, check the power status from on the display to determine whether the battery has sufficient charge to complete the monitoring session.

  • Page 25: Ecg

    BT-380 Operation manual 10 ECG 10.1 Overview Electrocardiogram (ECG) is produced by the continuous electrical activity of the patient's heart, and displayed with wave and numeric on the monitor in order to accurately assess the physiological state of the patient at the time. The ECG cable should be connected properly, so as to obtain a correct measurement value and normal display.
  • Page 26 BT-380 Operation manual 10.3.2 Selecting lead  Select the ECG parameter area → “ECG Setup” menu.  Select the ECG lead as needed.  “3-Lead”: 3-lead; ECG wave options: I, II, III.  “5-Lead”: 5-lead; ECG wave options: I, II, III, AVR, AVL, AVF, V.

  • Page 27: Ecg Display

    BT-380 Operation manual 10.4 ECG display  ECG wave display The monitor displays two ECG waves on the normal screen. Fig. 10-3 below is the monitoring interface of 5-lead, and is for reference purposes only. The graphics displayed on your monitor may be slightly different.

  • Page 28: Safety Information

    BT-380 Operation manual The monitor is defibrillation proof, so the monitor operates normally after defibrillation. 11.2 Safety information WARNING Please use SpO2 sensor specified in this Manual, operate in accordance with the Manual, and observe all  warnings and precautions.

  • Page 29: Measuring Influencing Factors

    BT-380 Operation manual  The user can set the pulse volume. The pulse volume can be set to Off, 1, 2, or 3. By default, the pulse volume is set to Off. 11.6 Measuring influencing factors During operation, the following factors can affect the accuracy of SpO measurement: ...

  • Page 30: Measurement Limits

    BT-380 Operation manual or any expected damage. Do not measure NIBP on traumatic body part. This may cause further injury. When pediatric patients are measured, in order to ensure the cuff pressure does not exceed its maximum  measurement range of patient types (Adult mode: 300mmHg and Pediatric mode: 240mmHg, Neonate mode: 150mmHg), you must ensure that you have selected the correct patient type (see patient information menu settings).

  • Page 31: Nibp Display

    BT-380 Operation manual Select the cuff in accordance with the following method, make sure that the cuff is completely deflated, and then tie it to the upper arm or thigh of the patient.  Determine the limb circumference of the patient.

  • Page 32: Alarm Setup

    “TEMP Sensor Off” prompt and make an alarm sound. Calibrate the temperature measuring instrument at least once every two years (or according to hospital  procedures). When calibration is required, please contact Bistos. 13.3 Measurement steps Please refer to the following steps: Turn on the monitor and check if it works normally.

  • Page 33: Alarm Setup

    BT-380 Operation manual  Select TEMP parameter area → “Mother” menu. In the “Mother” menu, set “Temp Unit” to “℃” or “℉” 13.7 Alarm setup In “Alarm” menu, select “NiBp/Temp” tab to enter “Temp Alarm” interface, and set TEMP alarm switch, upper and lower alarm limit.

  • Page 34: Overview

    BT-380 Operation manual 15.1 Overview The monitor has a built-in rechargeable battery to ensure that the monitor can also be used normally in case of patient transfer or power failure. When the monitor is connected to a power source, it will charge the battery no matter whether the monitor is turned on or not.

  • Page 35: Cleaning

    Wipe the monitor and sensor surface with medical alcohol, dry it naturally or with clean, dry, lint-free cloth.  Bistos is not liable for effectiveness of using these chemicals for infectious disease control. Please consult the  infectious disease control officers or experts of the hospital for advice.

  • Page 36: Viewing Software Version Information

    “Version” tab displays the software version information of the monitor. 17.3 Maintenance plan The following tasks can only be done by qualified service personnel of Bistos. When the following maintenance is needed, please contact your service representative. Before testing or maintenance, clean and disinfect the device.

  • Page 37: Specifications

    BT-380 Operation manual Description Type-number Manufacturer: ECG Cables and lead-wires Shenzhen Launch Electronics Tech CO., Ltd ECG electrodes(5) 98ME01AC009(AHA standard) or 98ME01EC009(IEC standard) Adult Finger Clip SpO Manufacturer: Sensor Unimed Medical Supplies,Inc SpO2 extension cable U403-01 Manufacturer: Adult Non-Invasive blood Shenzhen Med-link Electronics Tech Co.,Ltd...

  • Page 38: Functional Specification

    BT-380 Operation manual Type Color TFT touch screen LCD Size and resolution 10”, 1024*600 pixels Audio Alarm sound (45 ~ 85 dB), key pressing sound Speaker Doppler sound, QRS sound, PR sound Alarm sound meet the IEC 60601-1-8 standard requirements...
  • Page 39 BT-380 Operation manual For T-wave with 100ms QRS wave, 350ms QT period, 180ms duration and 1.2mV Tall T-wave suppression amplitude, the HR calculation will not be affected Without overshoot rejection of Amplitudes (ap) from ±2 mV to ±700 mV and pulse widths from 0.1 ms to 2.0 ms.

  • Page 40: Alarm Information

    BT-380 Operation manual NIBP Alarm 31 ~ 280 NIBP upper limit (mmHg) 11 ~240 1 mmHg step 11 ~ 220 30 ~ 279 NIBP lower limit (mmHg) 10 ~ 239 1 mmHg step 10 ~ 219 NIBP Electrical characteristics Supply voltage...

  • Page 41: Technical Alarm

    BT-380 Operation manual Source Alarm message Causes and countermeasures check if the patient category and alarm limit settings are HR Too Low appropriate for the patient. The patient ECG signal is too weak, and the system can’t analyze. ECG Signal weak Check the patient's condition, electrodes, cables and leads.

  • Page 42: Default Parameter Configuration

    BT-380 Operation manual Source Alarm message Causes and countermeasures condition of the patient, and place the cuff in a suitable position. If the failure persists, replace the cuff. NIBP signal unstable Excessive movement may result in too much motion artifact or interference in the signal during measurement.

  • Page 43: Common Faults And Maintenance

    Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies can affect the BT-380 and should be kept at least 1 m away from the equipment.

  • Page 44: Electromagnetic Immunity

    23.2 Recommended separation distances between portable and mobile RF communications equipment and BT-380 The BT-380 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the BT-380 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BT-380 as recommended below, according to the maximum output power of the communications equipment.
  • Page 45 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BT-380 is used exceeds the applicable RF compliance level above, the BT- 380 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-380.

  • Page 46: Product Warranty

    Sales Agency Manufacture Bistos Co., Ltd. ※ Thank you for purchasing BT-380. ※ 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”...

Table of Contents