Bistos BT-710 Operation Manual

Hand held pulse oximeter
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BT-710 Hand held pulse oximeter
Operation Manual
Keep this manual for future reference
P/N : 710-ENG-OPM-EUR-R02

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Summary of Contents for Bistos BT-710

  • Page 1 BT-710 Hand held pulse oximeter Operation Manual Keep this manual for future reference P/N : 710-ENG-OPM-EUR-R02...
  • 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 Co., Ltd.
  • Page 3: Table Of Contents

    BT-710 Operation manual Contents 0. Safety information……………………………………………………………………………………………………….4 0.1 General precautions, warnings and cautions……………………………………………………………………5 0.2 Shock hazards………………………………………………………………………………………………………………….8 0.3 Battery warnings……………………………………………………………………………………………………………..8 0.4 General precautions on environment…………………………………………………………………………….9 1. System basics …………………………………………………………………………………………………………….9 1.1 Intended use………………………………………………………………………………………………………………….9 1.2 Operating principle………………………………………………………………………………………………………..11 1.3 System configurations……………………………………………………………………………………………………11 1.4 Product outlook…………………………………………………………………………………………………………….11 1.5 Description of pulse oximeter………………………………………………………………………………………..11...
  • Page 4 BT-710 Operation manual 7.4 Alarm state……………………………………………………………………………………………………………………25 7.5 Alarm information…………………………………………………………………………………………………………25 8. Battery…………………………………………………………………………………………………………………………….26 8.1 Overview……………………………………………………………………………………………………………….………26 8.2 Battery usage guide……………………………………………………………………………………………………….27 8.3 Checking battery performance………………………………………………………………………………………28 8.4 Battery recycling……………………………………………………………………………………………………………28 9. Caring and cleaning…………………………..……………………………………………………………………………28 9.1 Overview……………………………………………………………………………………………………………………….28 9.2 Cleaning…………………………………………………………………………………………………………………………28 9.3 Disinfection……………………………………………………………………………………………………………………29 10. Maintenance…………………………………………………………………………………………………………………30 10.1 Checking………………………………………………………………………………………………………………………30 10.2 Trouble shootings………………………………………………………………………………………………………..30 10.3 Maintenance plan……………………………………………………………………………………………………….31...
  • Page 5: Safety Information

    BT-710 Operation manual 0 Safety information Before using BT-710 Pulse oximeter, 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 pulse oximeter.
  • Page 6: General Precautions, Warnings And Cautions

    • During the operation, do not disconnect any cable. • Do not operate the BT-710 pulse oximeter if it fails to pass the power on self-test pro- cedure. • The BT-710 pulse oximeter is intended to be used by clinical professionals or trained doctors, nurses or laboratory assistant.
  • Page 7 BT-710 Operation manual pulse oximeter, and only trained and qualified doctors and nurses should use the device. • The alarm volume, upper and lower alarm limits should be set according to the actual situation of the using environment. Do not just rely on audio alarm sys- tem while monitoring the patient, because too low alarm volume or muted alarm may result in notice failure of alarm situation and endanger the patient’s...
  • Page 8 • An operator may only perform maintenance procedures specifically described in this manual. • Do not remove the covers of a BT-710 yourself to avoid damage to the equip- ment and unexpected electrical shock. Only qualified Bistos service engineer must repair or replace components.
  • Page 9: Shock Hazards

    BT-710 Operation manual used within the patient vicinity (1.5m/6ft.). • Parts and accessories used must meet the requirements of the applicable safety standards, and/or the system configuration must meet the require- ments of the medical electrical systems standard. • Ensure that the conductive parts of electrodes and associated connectors, including neutral electrodes, do not come in contact with earth or any other conducting objects.
  • Page 10: General Precautions On Environment

    1 System basics 1.1 Intended use The BT-710 pulse oximeters acquire the blood oxygen saturation (SpO ) and pulse rate (PR). The signals are converted into digital data and processed, examines the data for alarm P/N : 710-ENG-OPM-EUR-R02 Bistos Co., Ltd.
  • Page 11 The BT-710 pulse oximeters are intended to be used only under regular supervision of clinical personnel. It is suitable for adult and pediatric, neonate. The intended locations of use are hospitals and clinics.
  • Page 12: Operating Principle

    BT-710 Operation manual 1.2 Operating principle Refer to the chapters for every physiological parameter from chapter 5. 1.3 System configurations Basic configuration of BT-710 • Main body with 4.3” touch screen and built-in lithium-ion battery • Adult SpO sensor probe •...
  • Page 13: Understanding The Display

    BT-710 Operation manual [Power] - Power Off: Press down the keys more than 2 seconds and the system will display the alarm message “The system will shut down 3 seconds”. To reset the alarm condition. [Alarm reset] Enter to the setting mode. Press again to close the setting mode.
  • Page 14: Essential Performance

    BT-710 Operation manual Description Current alarm message. When an alarm occurs, this area will displayed yellow or red depending on the alarm type. value. Display the measured SpO value. upper alarm limit. Display the user set upper alarm limit SpO2 lower alarm limit. Display the user set lower alarm limit waveform.
  • Page 15 2.1.1 Unpack and check BT-710 pulse oximeter 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. Unpack in the correct way, carefully remove the pulse oximeter and accessories from the box and check with the packing list.
  • Page 16: Connecting To Power

    WARNING • If the pulse oximeter is damaged, or fails to work normally, do not use it. Please contact the maintenance personnel or Bistos immediately. 3.1.2 Start the pulse oximeter If finish to check the pulse oximeter, it is ready to start the pulse oximeter.
  • Page 17: Turn Off

    BT-710 Operation manual - If the pulse oximeter equipped with a battery, charge the battery after each use to ensure sufficient power. - After unpacking and use the pulse oximeter at first time, the pulse oximeter should be powered with adapter.
  • Page 18: Spo

    BT-710 Operation manual and technical alarm conditions.  Select “Alarm Reminder Interval”, when the “Alarm Reminder Signal” sets “On”, you can choose alarm interval to “1min”, “2min”or “3min”.  Select key to display the following interface.  Select “Year”, “Month”, “Day”, “Hour”, “Minute” and “Second”, and set the current date.
  • Page 19: Safety Information

    5.2 Safety information WARNING • Please use SpO sensor supplied from Bistos, operate in accordance with the Manual, and observe all warnings and precautions. • Before monitoring, check whether the sensor probe is normal. When SpO sensor probe is unplugged from the socket, the screen will display “SpO2 No Sensor connected”...
  • Page 20: Monitoring Steps

    BT-710 Operation manual NOTE • Do not put the oxygen probe and blood pressure cuff on the same limb, be- cause blood flow occlusion during blood pressure measurement will affect the readings. • The pulse oximeter cannot be used to verify the accuracy of SpO probe and equipment.
  • Page 21: Measuring Influencing Factors

    BT-710 Operation manual  Select “Wave Mode”, and set the wave drawing mode to “Scan” or “Fill”. This displays a wave as line graph or filled line graph.  Select “Average Time”, and set the average time to “2-4s”, “4-8s”, “8-16s”. According to the selected option, the module displays the average of data collected within that time.
  • Page 22: Technical Description

    BT-710 Operation manual system or interference from electrosurgery instrument connected to the system.  Intravenous dye.  Too frequent movement of the patient.  External light radiation.  Sensor is improperly installed or improperly in contact with the patient.  Sensor temperature.
  • Page 23: Alarm

    BT-710 Operation manual To view historical data:  Press the [Setting] key twice to display the Trend screen.  Select key to page up and down to view patient data.  Press key to exit the Trend screen and display the...
  • Page 24: Alarm Types

    BT-710 Operation manual 7.1 Alarm types According to the nature of the alarm, the alarms of the monitor can be divided into physio- logical alarms, technical alarms, alarm reminder signal and prompt messages.  Physiological alarms A physiological alarm is usually triggered when a physiological parameter of the patient exceeds the alarm limit or the patient has physiological abnormalities.
  • Page 25: Alarm Mode

    BT-710 Operation manual 7.3 Alarm mode When an alarm occurs, the monitor uses the following audible or visual alarm to prompt the user:  Visual alarm  Audible alarm  Alarm info  Parameter flashing Of which, the visual alarm, audible alarm, and alarm information distinguish the alarm levels in a different manner respectively.
  • Page 26: Alarm State

    BT-710 Operation manual 7.4 Alarm state 7.4.1 Alarm reset Select button, and you can temporarily turn off the alarm sound of currently occurring physiological alarms of the pulse oximeter, but the alarm information is still retained. For technical alarms, clear the alarm state, display alarm prompt information, the alarm state icon area displays the icon.
  • Page 27: Battery

    BT-710 Operation manual PI value is higher than the settled upper PI High PI Too alarm limit or lower than the settled lower 0.00 Limit High alarm limit. Check the patient's physiological condition, and when the PI alerts the PI Too PI Low limit 20.00...
  • Page 28: Battery Usage Guide

    BT-710 Operation manual Battery is working properly and the green part indicates the battery power. Battery power is low, and requires charging immediately, or else the pulse oxime- ter will turn off automatically. Battery is not installed. Battery is properly installed and being charged.
  • Page 29: Checking Battery Performance

    BT-710 Operation manual 8.3 Checking battery performance Please refer to the following steps to check the battery performance:  Disconnect the pulse oximeter from the patient and stop the monitoring or measurement.  Connect DC power to the monitor, and charge the battery for more than 4 hours uninter- ruptedly.
  • Page 30: Disinfection

    • Wipe the pulse oximeter 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 ex- perts of the hospital for advice.
  • Page 31: Maintenance

     Ground impedance and leakage current meet the requirements. All checks that require disassembling the instrument must be performed by qualified service personnel. Safety and maintenance checks may also be carried out by the Bistos personnel. 10.2 Trouble shootings Problem Solution Check the battery.
  • Page 32: Maintenance Plan

    10.3 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 33: Specifications

    BT-710 Operation manual 12 Specifications 12.1 Safety specifications 12.1.1 Product category In accordance with classification specified in the European Medical Device Directive 93/42/EEC, this pulse oximeter is Class IIb device. The pulse oximeter is classified as follows in accordance with IEC 60601-1:...
  • Page 34 BT-710 Operation manual accuracy ±2% (at the range 70%~100%)(adult/pediatric mode) ±3% (at the range 70%~100%) (neonate mode) not define when lower than 70% ; Measurement accuracy verification The SpO accuracy has been verified in human experi- ments by comparing with arterial blood sample refer- ence measured with a CO-oximeter.
  • Page 35: Manufacturer's Declaration On Emc

    13.1 Electromagnetic emissions The BT-710 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-710 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The BT-710 uses RF energy only for its internal function.
  • Page 36: Recommended Separation Distances Between Portable And Mobile Rf Communications

    13.3 Electromagnetic immunity The BT-710 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-710 should assure that it is used in such an environment. IEC 60601 Test Electromagnetic environment -...
  • Page 37 NOTE Uт is the a.c. mains voltage prior to application of the test level. The BT-710 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-710 should assure that it is used in such an environment. Immunity test...
  • Page 38: Product Warranty

    Manufacture Bistos Co., Ltd. ※ Thank you for purchasing BT-710. ※ 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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