Related Manuals for Bistos BT-710
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-D01...
- 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.
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Page 3: Table Of Contents
BT-710 Operation manual Contents 0. Safety information ······················································································· 4 0.1 General precautions, warnings and cautions ···························································· 6 0.2 Shock hazards ············································································································· 10 0.3 Battery warnings········································································································· 11 0.4 General precautions on environment ······································································· 12 1. System basics ······························································································· 13 1.1 Intended use ··············································································································· 14 1.2 Operating principle ·····································································································... - Page 4 13. Manufacturer’s declaration on EMC ····························································· 46 13.1 Electromagnetic emissions ······················································································· 47 13.2 Recommended separation distances between portable and mobile RF communications equipment and BT-710 ····································································································· 48 13.3 Electromagnetic immunity ······················································································· 49 Product Warranty ······························································································ 51 Figure 1-1: Front view ············································································································ 15 Figure 1-2: Rear view ·············································································································...
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Page 5: Safety Information
BT-710 Operation manual 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 BT-710 Operation manual Indicates the date after which the medical device is not to be used. Indicates to keep the device dry. Indicates the medical device that can be broken or damaged if not handled carefully. Indicates to keep upright Indicates the maximum stacking limit.
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Page 7: 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 • procedure. The BT-710 pulse oximeter is intended to be used by clinical professionals or trained •... - Page 8 BT-710 Operation manual system 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 safety. Please pay close attention to the actual clinical status of the patient.
- Page 9 • 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 • equipment and unexpected electrical shock. Only qualified Bistos service engineer must repair or replace components.
- Page 10 BT-710 Operation manual Any non-medical equipment (such as the external printer) is not allowed to be • 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 requirements of the medical electrical systems standard.
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Page 11: Shock Hazards
BT-710 Operation manual 0.2 Shock hazards WARNING Unplug the pulse oximeter from its power source prior to cleaning or maintenance to prevent personal injury or equipment damage. Some chemical cleaning agents may be conductive and leave a residue that may ... -
Page 12: Battery Warnings
BT-710 Operation manual 0.3 Battery warnings WARNING Improper operation may cause the internal lithium ion battery to be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It is necessary to read the operation manual carefully and pay more attention to warning message. -
Page 13: General Precautions On Environment
BT-710 Operation manual 0.4 General precautions on environment Do not keep or operate the pulse oximeter under the environment listed below. Avoid placing in an area exposed to moisture. Do Avoid exposure to direct not touch the pulse sunlight oximeter with wet hand. -
Page 14: System Basics
The BT-710 pulse oximeters are intended to be used only under regular supervision of clinical personnel. It is suitable for adult and pediatric. The intended locations of use are hospitals and clinics. -
Page 15: Operating Principle
Source: NHS. “Clinical Procedure_ Procedure for Pulse Oximetry/SPO2”. Wirral Community NHS Trust. Sep, 2013 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 •... -
Page 16: Product Outlook
BT-710 Operation manual 1.4 Product outlook Figure1-1: Front view Figure1-2 : Rear view P/N : 710-ENG-OPM-EUR-D01 Bistos Co., Ltd. 2018.05... - Page 17 BT-710 Operation manual Figure1-3 : Top view Figure1-4 : Bottom view P/N : 710-ENG-OPM-EUR-D01 Bistos Co., Ltd. 2018.05...
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Page 18: Description Of Pulse Oximeter
BT-710 Operation manual 1.5 Description of pulse oximeter Figure1-5: Front view Name Description Turned on when the pulse oximeter is being powered by DC power indicator the adapter. Display area Display the waveform and measured value - Power On: Press down the key more than 2 seconds. - Page 19 BT-710 Operation manual Figure1-6: Top view Name Description cable interface Figure1-7: Bottom view Name Description SD card interface For software upgrade Power adapter 5V, 1A adapter Lanyard eyelet For convenient hand held P/N : 710-ENG-OPM-EUR-D01 Bistos Co., Ltd. 2018.05...
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Page 20: Understanding The Display
BT-710 Operation manual 1.6 Understanding the display Figure 1-8: Standard display Description Current alarm message. When an alarm occurs, this area will displayed yellow or white 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. -
Page 21: Essential Performance
BT-710 Operation manual 1.7 Essential performance This device Pulse oximeter provides patient vital signs such as pulse rate, blood oxygen saturation and perfusion index by placing the sensors to the appropriate site of patient. The device is composed with display, control circuit and panel, and input part for SpO sensors. -
Page 22: Preparing For Operation
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 23: Environmental Requirements
BT-710 Operation manual 2.1.3 Environmental requirements The storage, transport and use of the pulse oximeter must meet the following environmental requirements. Ambient temperature 5℃ ~ 40 ℃ Operating Relative humidity 30 % ~ 85 % (Non-condensing) environment Atmospheric pressure 700 ~ 1060 mbar (hPa) Transportation Prevent severe shock, vibration, rain and snow splashing during transport. -
Page 24: Basic Operations
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 25: Start Monitoring
BT-710 Operation manual 3.1.4 Start monitoring Start monitoring in the following steps: Check if the patient cable and the sensor are connected properly. Check if the settings of the pulse oximeter are corrects, such as patient type. 3.2 Turn off Turn off the pulse oximeter in the following steps Disconnect the cables and sensors connected to the patient. -
Page 26: Setup The Pulse Oximeter
BT-710 Operation manual Setup the pulse oximeter In the main screen, Press the key enter the setup menu. Select “Patient Type”, you can choose “Adult” or “Pediatric”. Select “Alarm Delay”, you can choose off, 1s, 2s, 3s, 4s, 45s, 5s, 6s, 7s or 8s. - Page 27 BT-710 Operation manual Select “Year”, “Month”, “Day”, “Hour”, “Minute” and “Second”, and set the current date. Select “Date Format”, and set the date format in accordance with custom “YYYY-MM-DD”: Year- Month-Day. “MM-DD-YYYY”: Month -Day-Year. “DD-MM-YYYY”: Day-Month-Year.
- Page 28 BT-710 Operation manual Select “Screen Setup”, set “SpO2”. Select “Language”, and select the option as needed: “English”: The interface language of the pulse oximeter is English. “Türkçe”: The interface language of the pulse oximeter is Turkish. “ Español ”: The interface language of the pulse oximeter is Spanish .
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Page 29: Spo
BT-710 Operation manual 5.1 Overview Blood oxygen saturation (SpO ) is the percentage of oxyhemoglobin (HbO2) capacity bound by oxygen in the blood in the total hemoglobin (Hb) capacity that can be combined, that is, the concentration of oxygen in the blood. -
Page 30: Safety Information
BT-710 Operation manual 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 cable is normal. When SpO sensor ... -
Page 31: Monitoring Steps
BT-710 Operation manual 5.3 Monitoring steps Select the appropriate SpO sensor according to the patient. Turn on the pulse oximeter, and connect the SpO lead wire to the pulse oximeter. Clean the measurement site, such as finger with nail polish. - Page 32 BT-710 Operation manual Select “Pulse Volume”, and set the pulse volume to ‘0’, ‘1’, ‘2’, ‘3’, ‘4’, ‘5’, ‘6’, ‘7’, ‘8’, or ‘9’. Select key to display the following interface. Select “SpO2 Low Limit”, and enter value (Range: 0-99), Adult/Pediatric default: 90.
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Page 33: Measuring Influencing Factors
BT-710 Operation manual 5.5 Measuring influencing factors During operation, the following factors can affect the accuracy of SpO measurement: High-frequency radio wave interference, such as interference generated by the host system or interference from electrosurgery instrument connected to the system. -
Page 34: Review
BT-710 Operation manual Review Use the trend screen to recall all the historical patient data in a list, including monitoring time (in 1-minute intervals), and SpO and PR values. The most recent measurements display at the top of the list. - Page 35 BT-710 Operation manual Figure 6-2: SpO Trend (2) Select ‘SpO2’, ‘PR’ or ‘PI’ to see. Press key to exit the Trend screen and display the Main screen. P/N : 710-ENG-OPM-EUR-D01 Bistos Co., Ltd. 2018.05...
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Page 36: Alarm
BT-710 Operation manual Alarm 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 37: Battery
BT-710 Operation manual Battery The pulse oximeter has a built-in rechargeable battery to ensure that the pulse oximeter can also be used normally in case of patient transfer or power failure. When the oximeter is connected to a DC power source, it will charge the battery no matter whether the pulse oximeter is turned on or not. -
Page 38: Battery Usage Guide
BT-710 Operation manual 8.1 Battery usage guide Battery life depends on the frequency and time of use. If the battery maintenance and storage are proper, the lithium battery life is three years. If you do not use the battery properly, its life may be shortened. -
Page 39: Checking Battery Performance
BT-710 Operation manual 8.2 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 ... -
Page 40: Caring And Cleaning
BT-710 Operation manual Caring and cleaning 9.1 Overview In the using process, please make sure that there is no dust on or near your device. To prevent damage, please use the diluted detergents and disinfectants specified in this manual, and use the lowest possible concentration. -
Page 41: 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 experts of the hospital for advice. -
Page 42: 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. P/N : 710-ENG-OPM-EUR-D01 Bistos Co., Ltd. -
Page 43: Trouble Shootings
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 44: Accessories
BT-710 Operation manual Accessories WARNING Use the accessories specified in this manual. Using other accessories may • damage the monitor, or cannot reach the safety and performance claimed in this manual. The operating and storage environment of the monitor should meet the •... -
Page 45: Specifications
BT-710 Operation manual 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 46: Functional Specification
BT-710 Operation manual 12.3 Functional specifications Standards compliant ISO 80601-2-61:2011 Display range 0% ~ 100% display resolution accuracy ±2% (70%~100%) not define when lower than 70% ; alarm limit range Upper alarm limit 1%~100% Lower alarm limit 0%~99% alerting signal... -
Page 47: Manufacturer's 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-710 and should be kept at least 1 m away from the equipment. -
Page 48: Electromagnetic Emissions
BT-710 Operation manual 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 49: Recommended Separation Distances Between Portable And Mobile Rf Communications
13.2 Recommended separation distances between portable and mobile RF communications equipment and BT-710 The BT-710 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the BT-710 can help prevent... -
Page 50: Electromagnetic Immunity
BT-710 Operation manual 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 Electromagnetic Immunity test... - Page 51 BT-710 Operation manual 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 IEC 60601 test level Compliance level...
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Page 52: Product Warranty
Sales Agency 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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