Bistos BT-770 Operation Manual

Bistos BT-770 Operation Manual

Patient monitor
Table of Contents

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BT-770 Patient monitor
Operation Manual
Keep this manual for future reference
P/N : 770-ENG-OPM-EUR-D03

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Questions and answers

Bounadi Belkacem
February 13, 2025

Passe word

SYLVESTER KASONDE
February 17, 2025

Our BT-770 monitors are displaying similar alarm messages: SPO2 and NIBP comm stop. Restarting the device is not helping and our technicians have failed to rectify the issues.

Summary of Contents for Bistos BT-770

  • Page 1 BT-770 Patient monitor Operation Manual Keep this manual for future reference P/N : 770-ENG-OPM-EUR-D03...
  • 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-770 Operation manual Contents 0. Safety information ······················································································ 6 0.1 General precautions, warnings and cautions ···························································· 9 0.2 Shock hazards ············································································································· 13 0.3 Battery warnings········································································································· 14 0.4 General precautions on environment ······································································· 15 1. System basics ······························································································ 16 1.1 Intended use ··············································································································· 16 1.2 Operating principle ·····································································································...
  • Page 4 BT-770 Operation manual 6.4 Alarm states ················································································································ 53 6.5 Alarm setup ················································································································· 56 6.6 Latch alarm ················································································································· 58 6.7 Manual event ············································································································· 59 6.8 Alarm record ·············································································································· 59 7. ECG ·············································································································· 60 7.1 Overview ····················································································································· 60 7.2 Safety information ····································································································· 61 7.3 Monitoring steps ········································································································...
  • Page 5 21. Common faults and maintenance ······························································· 117 22. Manufacturer’s declaration on EMC ··························································· 118 22.1 Electromagnetic emissions ······················································································· 119 22.2 Recommended separation distances between portable and mobile RF communications equipment and BT-770 ····································································································· 120 22.3 Electromagnetic immunity ······················································································· 121 P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd.
  • Page 6 BT-770 Operation manual Product Warranty ······························································································ 123 Figure 1-1: Front view ············································································································ 21 Figure 1-2: Side view ············································································································· 21 Figure 1-3: Rear view ············································································································· 22 Figure 1-4: Front view ············································································································ 23 Figure 1-5: Side view ············································································································· 24 Figure 1-6: Rear view ············································································································· 25 Figure 1-7: Standard display ··································································································...
  • Page 7: Safety Information

    BT-770 Operation manual Safety information Before using BT-770 Patient 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 patient monitor.
  • Page 8 BT-770 Operation manual Indicates USB interface. Indicates power adapter polarity. Indicates the production date. Indicates the manufacturer. Indicates the serial number of the device. Indicates the authorized representative in the European Community of manufacturer. Indicates a defibrillation-proof type BF applied part.
  • Page 9 BT-770 Operation manual Indicates the device contains natural rubber latex.(Accessories) Indicates the packing material is recyclable. Indicates to not dispose the device together with unsorted municipal waste(for EU only). The solid bar symbol indicates that mains adapter is put on the market after 13 August 2005.
  • Page 10: General Precautions, Warnings And Cautions

    Beyond the conditions, the patient monitor may not function properly and the measurement results may not accurate and may result in device failure or endangering the patient’s safety. Do not operate the BT-770 patient monitor if it fails to pass the power on self-test • procedure.
  • Page 11 BT-770 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 12 • An operator may only perform maintenance procedures specifically described in this manual. Do not remove the covers of a BT-770 yourself to avoid damage to the • equipment and unexpected electrical shock. Only qualified Bistos service engineer must repair or replace components.
  • Page 13 BT-770 Operation manual instruction for use, in risk of external high voltage. • Do not connect any equipment or accessories that are not approved by the manufacturer or according to IEC 60601-1 to the monitor. The operation or use of non-approved equipment or accessories with the monitor is not tested or supported, and monitor operation and safety are not guaranteed in such a case.
  • Page 14: Shock Hazards

    BT-770 Operation manual 0.2 Shock hazards WARNING Unplug the monitor 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 15: Battery Warnings

    BT-770 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 16: General Precautions On Environment

    Power off when the Do not disjoint or equipment is not fully disassemble the device. ready to operate. Bistos Co., Ltd. does not Otherwise, the have liability of it. equipment could be damaged. P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd.
  • Page 17: System Basics

    The BT-770 patient monitors are intended to be used only under regular supervision of clinical personnel. It is suitable for adult and pediatric.
  • Page 18 BT-770 Operation manual 5) Indications and contraindications Blood oxygen saturation (SpO Indication: Monitoring effectives of oxygen therapy A reading is needed to facilitate the completion of an early warning score to inform clinical assessment Sedation or anesthesia Transport of patients who are unwell and require oxygenation assessment Haemodynamic instability (e.g.
  • Page 19: Operating Principle

    BT-770 Operation manual Electrocardiography (ECG) Indication: The electrocardiogram (ECG) has proven to be among the most useful diagnostic test in clinical medicine. It is routinely used in the evaluation of patients to detect myocardial injury, ischemia and the presence of prior infarction, in the assessment of patients with electrolyte abnormalities, drug toxicities and implanted defibrillators and pacemakers.
  • Page 20: System Configurations

    BT-770 Operation manual 1.3 System configurations Basic configuration of BT-770 • Main body with 12 inch touch screen and built-in lithium-ion battery • ECG cable and electrode • Adult SpO2 probe and extension cable • Non-invasive blood pressure cuff •...
  • Page 21 BT-770 Operation manual Picture Name Description ECG cable and lead wire Measures ECG (standard) ECG electrode Electrode for ECG measurement (standard) Adult SpO2 sensor SpO2 sensor for adult (standard) extension Cord to connect the SpO2 sensor and cord main body...
  • Page 22: Product Outlook

    BT-770 Operation manual 1.4 Product outlook Figure1-1: Front view Figure1-2 : Side view P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd. 2018.05...
  • Page 23: Figure 1-3: Rear View

    BT-770 Operation manual Figure1-3 : Rear view P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd. 2018.05...
  • Page 24: Description Of Monitor

    BT-770 Operation manual 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. Alarm indicator High priority: Red, fast flashing (1.4 - 2.8 Hz) Medium priority: Yellow, slow flashing (0.4 - 0.8 Hz)
  • Page 25: Figure 1-5: Side View

    BT-770 Operation manual To pause the alarm sound. Alarm pause time can be set as 1 , 2, 3, 4, 5, 10, 15 minutes, and permanent. Default [Alarm pause] setting is 2 minutes. Start and stop the non-invasive blood pressure measurement.
  • Page 26: Figure 1-6: Rear View

    BT-770 Operation manual Name Description Temperature probe interface Temperature probe interface SpO2 SpO2 cable interface ECG cable interface NIBP NIBP cuff interface Figure1-6: Rear view Name Description Handle Handle for main body transport Speaker holes For alarm and synchronizing sound...
  • Page 27 BT-770 Operation manual Bracket To wall mount the monitor ID label Identify the monitor information Air intake For ventilation Auxiliary output interface Nurse call Network port For CMS USB port For trend or software upgrade Power adapter 15V, 2.4A adapter P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd.
  • Page 28: Understanding The Display

    BT-770 Operation manual 1.6 Understanding the display Figure 1-7: Standard display Name Description Include patient information, alarm status icon, Information area physiological and technical alarms. In DEOM mode, it displays “DEMO”. Mainly display the waves of physiological Waveform area parameters with name of the parameter on the left side.
  • Page 29: Smart Hotkeys

    BT-770 Operation manual 1.7 Smart Hotkeys Smart hotkeys are graphic hotkeys displayed at the bottom of the main screen of the monitor, and enable the user to use specific features conveniently. Name Description [Pause] Alarm pause [Pat. Set] Patient information setting...
  • Page 30: Preparing For Operation

    2.1.1 Unpack and check BT-770 patient 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. Unpack in the correct way, carefully remove the monitor and accessories from the box and check with the packing list.
  • Page 31 BT-770 Operation manual 2.1.2 Placement requirements Equipment installation must meet: The left and right side of the monitor should have space more than 100 cm from the wall Back on the monitor should have space more than 50 cm. Ensure that the operating floor and the monitor have enough space for connecting the accessory wires.
  • Page 32: Connecting To Power

    BT-770 Operation manual 2.2 Connecting to power WARNING Do not try to open the monitor when the power is connecting.  During the operation, do not disconnect any cable.  Connect to power adapter in the following steps: Make sure that the AC power supply meets the following specifications: a.c.100V- 240V, 50/60Hz.
  • Page 33: 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 34: Turn Off

    BT-770 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 monitor are corrects, such as patient type. For the details of parameter measurement or monitoring, see the appropriate section.
  • Page 35 BT-770 Operation manual 3.3.2 Using keys The monitor has three types of keys: Soft keys: Within the display these keys allow quick access to certain menus or performing certain actions, including: • Parameter hotkeys: Select a parameter area and enter the appropriate parameter setup menu, including drug calculation and time setup.
  • Page 36: Figure 3-1: "Settings" Menu

    BT-770 Operation manual 3.3.5 Using menu Select the [Settings] smart key on the monitor or press the [Setting] key on the monitor panel to open the “Settings” 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”, and generally consists of the...
  • Page 37: Operation Mode

    BT-770 Operation manual 3.4 Operation mode The monitor has 2 operating modes, of which the demo mode is protected by a password. 1. Monitoring mode (operating mode) This is the daily operating mode of patient monitoring; you can change some settings in accordance with the patients, such as alarm limits.
  • Page 38: Freezing Waves

    BT-770 Operation manual 3.6 Freezing waves In the patient monitoring process, you can freeze the wave on the screen, review and carefully observe the patient's condition during this time. Freeze / unfreeze the wave as follows: Select 【Freeze】 hotkey or press the [Freeze] key on the monitor panel to freeze the displayed wave of the monitor.
  • Page 39 BT-770 Operation manual 3.7.2 Language setup Set the monitor language in the following steps: Select [Settings]Smart Hotkey or press [Setting] key on the monitor panel →  “Settings”. Select “User Maintenance >>” →enter the password and confirm →“User Maintenance” ...
  • Page 40 BT-770 Operation manual 3.7.4 Volume control Alarm Volume Select 【Volume】smart hotkey → “Volume Setup” menu.  Select “Alarm Volume”: Set alarm volume from 1 to 9.  QRS Volume Select 【Volume】smart hotkey → “Volume Setup” menu.  Select “QRS Volume”: Set QRS volume from 0 to 9. 0 means off.
  • Page 41 BT-770 Operation manual “ST Unit” fixed as “mV”, is not optional.  Select “Pressure Unit”, and select the unit “mmHg” / “kPa” as needed.  Select “TEMP Unit”, and select the unit “℃” / “℉”as needed.  P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd.
  • Page 42: Patient Information Management

    BT-770 Operation manual Patient information management Connect the patient to the monitor, and the monitor will display and store the physiological data of the patient, so the patient can be monitored without admitting the patient. However, admitting the patient correctly is very important.
  • Page 43: Admitting A Patient

    BT-770 Operation manual Figure 4-1 “Patient” menu 4.2 Admitting a patient Admit a patient as follows: In “Patient” menu, select “Quick Admit” → “Warning” message → “OK” → “Quick Admit” menu, as shown in Figure 4-2. Figure 4-2 “Quick Admit” menu Select “Patient Type”, and set the patient category as needed: “Adult”...
  • Page 44: Patient Information

    BT-770 Operation manual 4.3 Patient information To edit patient information, operate as follows: In the “Patient” menu, select “Patient Info”. The “Patient Info” menu as shown in Figure 4-3 will be displayed. Figure 4-3. “Patient Info” menu Select “Last Name”, and enter patient’s surname through the soft keyboard(Letters: not more than 20 characters).
  • Page 45: Discharging A Patient

    BT-770 Operation manual Select “Height(cm)”, and set the patient’s height via the pop-up keyboard on the screen(Range: 0~250). Select “Weight (kg)”, and set the patient’s weight via the pop-up keyboard on the screen(Range: 0~350). 10. Select “Blood Type”, and set the patient’s blood type: A, B, AB or O.
  • Page 46: Clear Nibp Trend

    BT-770 Operation manual 4.7 Clear NIBP trend To clear NIBP trend, operate as follows: In the “Patient” menu, select “Clear NIBP Trend” → “Warning” message → “OK” to finish the operation of clear NIBP trend. After the NIBP trend was cleared, all the information of NIBP trend stored in the monitor will be cleared.
  • Page 47: Display Format

    BT-770 Operation manual Display format The monitor has four display format, which are “Normal Screen”, “Big ECG Screen”, “Big font Screen”, and “ECG 7-Lead Full-Screen”. The user can select the display format according to needs, and get different screen information.
  • Page 48: Display Description

    BT-770 Operation manual 5.2 Display description 5.2.1 Normal display format Figure 5-1: Standard Display The normal display provides the parameter wave being monitored and the parameters displayed in the parameter area. This is the basic display of the monitor. In this display mode all parameters, two ECG waves, one blood oxygen saturation percentage wave, one respiratory wave are displayed.
  • Page 49: Figure 5-2: Big Ecg Format

    BT-770 Operation manual Figure 5-2: Big ECG format 5.2.3 Big font format The big font format is as shown in Figure 5-3. Figure 5-3: Big font format P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd. 2018.05...
  • Page 50: Figure 5-4: Ecg 7-Lead Full Screen Format

    BT-770 Operation manual 5.2.4 ECG 7-Lead full screen format The ECG 7-Lead full screen format is as shown in Figure 5-4. Figure 5-4: ECG 7-Lead full screen format P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd. 2018.05...
  • Page 51: Alarm

    BT-770 Operation manual Alarm Alarm means that the monitor prompts the medical staff through sound and light when the abnormal changes in vital signs are monitored or the monitor has a failure or is unable to monitor the patient successfully.
  • Page 52: Alarm Mode

    BT-770 Operation manual Medium priority alarms  The patient's physiological signs are abnormal and appropriate measures or treatment should be taken immediately, or although it won’t endanger the patient’s life, the mechanical failure or disoperation of the monitor will affect the normal monitoring of key physiological parameters.
  • Page 53 BT-770 Operation manual High priority alarm: Beep-beep-beep--beep-beep----beep-beep-beep--beep-beep  Medium priority alarm: Beep-beep-beep  Low priority alarm: Beep  6.3.3 Alarm information Alarm information displayed on the physiological or technical alarm area of the monitor indicates the corresponding alarm information when an alarm occurs. The system will...
  • Page 54: Alarm States

    BT-770 Operation manual 6.4 Alarm states In addition to the above alarm modes, you can also set the monitor to the following three alarm states as needed, and display different alarm icons on the screen: Alarm Reset  Alarm sound off ...
  • Page 55 BT-770 Operation manual 6.4.3 Alarm pause Press the [Pause] smart hotkey or [Alarm pause] key on the monitor panel to temporarily stop the alarm of the monitor in the following steps: [Pause]smart hotkey will appear magnified and reverse colored icon.
  • Page 56 BT-770 Operation manual 6.4.4 Alarm off As shown in 6.4.3, if the “Alarm Pause Time” is set to “Permanent”, press the [Pause] smart hotkey or [Alarm pause] key on the monitor panel, and the monitor will turn off the alarm.
  • Page 57: Alarm Setup

    BT-770 Operation manual 6.5 Alarm setup 6.5.1 Setting the alarm delay time To limit alarm of continuous measurement parameter, you can set the alarm delay time. If the alarm condition disappears during the delay period, the monitor will not generate an alarm. In “Alarm Param”...
  • Page 58 BT-770 Operation manual “On”: The alarm Reminder Signal is on.  “Off”: The alarm Reminder Signal is off.  Select “Alarm Reminder Interval”, and set the alarm reminder interval as needed:  “1min” / “2 min” / “3 min”: Alarm reminder interval is 1 min, 2 min or 3 min. By ...
  • Page 59: Latch Alarm

    BT-770 Operation manual Type Adults Pediatric Range Default Range Default SpO2 Low Limit 0-99 0-99 SpO2 High Limit 1-100 1-100 PR Low Limit 15-299 15-349 PR High Limit 16-300 16-350 Restore default alarm setup Select “Default”, and restore the alarm setup to the factory setup.
  • Page 60: Manual Event

    BT-770 Operation manual 6.7 Manual event In the patient monitoring process, some events may have an impact on the patient, resulting in changes of some monitoring waves or parameters. In order to assist in the analysis of these effects, you can...
  • Page 61: Ecg

    BT-770 Operation manual 7.1 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 62: Safety Information

    BT-770 Operation manual 7.2 Safety information WARNING To monitor ECG signal, ECG cable and ECG electrodes specified in this manual  must be used. When connecting the electrodes or patient cable, make sure that the patient is  absolutely not connected with any other conductive parts or in contact with the ground.
  • Page 63: Monitoring Steps

    BT-770 Operation manual 7.3 Monitoring steps 7.3.1 Preparation Before placing the electrode, prepare the patient’s skin in the following steps. Skin preparation: Since the skin is a poor conductor, it is very important to treat the  patient's skin for electrode placement appropriately to make good contact between the electrode and the skin.
  • Page 64: Figure 7-1: 3-Lead Placement Method

    BT-770 Operation manual 7.3.3 Lead name and corresponding color The lead names in European standard and U.S. standard (represented with R, L, N, F, C in European Standard, and represented with RA, LA, RL, LL, V in the U.S. standard) are shown in Table 9 -1.
  • Page 65: Figure 7-2: 5-Lead Placement Method

    BT-770 Operation manual 5-lead  The electrode placement position of 5-lead is shown in Fig. 9-2: R/RA electrode: placed below the clavicle, near the right shoulder.  L/LA electrode: placed below the clavicle, near the left shoulder.  N/RL electrode: placed on the right abdomen.
  • Page 66 BT-770 Operation manual 7.3.5 Checking the pacemaker Before ECG monitoring, it is very important to set the pace maker state of the patient properly. If the patient has a pacemaker, set “Pace Maker” to “Yes”, and the icon displays in the patient information area.
  • Page 67: Ecg Display

    BT-770 Operation manual 7.4 ECG display ECG wave display  The monitor displays two ECG waves on the normal screen. Fig. 7-3 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 68: Ecg Setup

    BT-770 Operation manual 7.5 ECG setup Select the ECG parameter area or wave ECG area or select the [Settings] smart hotkey and “Parameter Setup >>” and “ECG Setup >>” to pop up the “ECG Setup” menu, which is as shown below.
  • Page 69: Alarm Setup

    BT-770 Operation manual wave gain factor appropriately; when the wave is high or the peak cannot be displayed, reduce the wave gain appropriately, gain can be set Auto/×0.25/×0.5/×1/×2. When Big ECG interface is selected, gain can be set Auto/×0.25/×0.5/×1/×2/×4. Select “Wave Speed”, and set the wave speed. The wave speed is ...
  • Page 70: Resp

    BT-770 Operation manual RESP 8.1 Overview Thoracic electrical bio impedance is a method used for measuring the respiration. When the patient is breathing, the thoracic impedance between two ECG electrodes changes due to thoracic activity. The monitor generates a respiratory wave on the screen by measuring the changing impedance value.
  • Page 71: Placing Electrodes For Respiration Monitoring

    BT-770 Operation manual 8.3 Placing electrodes for respiration monitoring Since the skin is a poor conductor, it is very important to treat the patient's skin for electrode placement appropriately to get better respiration signals. Refer to 7.3.1. Respiration measurement uses standard ECG cable and electrode placement method. You can use different ECG cables (3-lead or 5-lead).
  • Page 72: Respiration Display

    BT-770 Operation manual 8.3.2 Cardiomotility superimpose The effect of cardiomotility on the respiratory wave is called cardiomotility superimposing. When the respiration electrodes collect impedance changes caused by rhythmic blood flow, this will happen. Placing the respiration electrodes correctly will reduce this effect. The liver and ventricle should avoid the connection of respiration electrode, so that the heart or pulsating flow won’t generate artifact.
  • Page 73: Respiration Setup

    BT-770 Operation manual 8.5 Respiration setup Select the RESP parameter zone or respiration wave area → “RESP Setup” menu, which is shown below. You can set respiration through “RESP Setup” menu. Figure 8-4: “RESP Setup” menu 8.5.1 Setting apnea time Apnea alarm is a high level alarm for monitoring the apnea.
  • Page 74: Alarm Setup

    BT-770 Operation manual 8.5.4 Setting calculated channel In “RESP Setup” menu, select “Calculated Channel”, and set the calculated channel. The calculated channels are “RA-LA”, “RA-LL”, “LA-RL” and “LL-RL”. The default is “RA-LA”. 8.5.5 Setting sensitivity In “RESP Setup” menu, select “sensitivity”, and set the sensitivity. The sensitivity is “1” / “2” / “3”...
  • Page 75: Overview

    BT-770 Operation manual 9.1 Overview The mechanical activity of the heart causes arterial pulsation, and PR (pulse rate) value can be obtained by measuring this pulsation. PR value can be obtained through SpO measurement. The average calculation of the heart rate is the direct average method. The refresh rate is every 1 second.
  • Page 76: Spo

    BT-770 Operation manual 10.1 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 77 BT-770 Operation manual Do not put the sensor on limbs with arterial duct or intravenous tube.  Do not intertwine electrosurgical equipment cable with the sensor cable.  Avoid using the monitor and sensors while using the NMR equipment, in order to ...
  • Page 78: Monitoring Steps

    BT-770 Operation manual 10.3 Monitoring steps Select the appropriate SpO sensor according to the patient. Turn on the monitor, and connect the SpO lead wire to the monitor. Clean the measurement site, such as finger with nail polish. Put the SpO sensor probe on the patient’s body.
  • Page 79: Display

    BT-770 Operation manual 10.4 Display SpO2 parameter area is as shown in figure 10-1. Figure 10-1: SpO parameter display SpO2 wave is as shown in figure 10-2. Figure 10-2: SpO wave P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd. 2018.05...
  • Page 80: Setting Spo

    BT-770 Operation manual 10.5 Setting SpO Select SpO parameter area or SpO wave area → “SpO Setup” menu, which is shown below. You can set SpO through “SpO Setup” menu. Figure 10-3: “SpO2 Setup” menu 10.5.1 Setting wave speed Select “Wave Speed” and set wave speed to “12.5mm/s” or “25mm/s”; the faster speed, ...
  • Page 81: Measuring Influencing Factors

    BT-770 Operation manual 10.6 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 82: Technical Description

    BT-770 Operation manual 10.8 Technical description Accessories have passed the biocompatibility test and meet the requirements of ISO  10993-1. Fluke's index 2XL Oxygen Analyzer can be used to check the function of the monitor and  can be used to assess the accuracy of the pulse rate but cannot be used to assess the accuracy of blood oxygen.
  • Page 83: Nibp

    BT-770 Operation manual NIBP 11.1 Overview The monitor uses oscillometric method to measure noninvasive blood pressure (NIBP). The oscillometric method for measuring blood pressure is to inflate a cuff with a certain amount of pressure until the arterial blood flow has been completely blocked. As applied pressure decreases, the arterial blood flow which was completely occluded gradually opened, and completely opened.
  • Page 84: Safety Information

    BT-770 Operation manual 11.2 Safety information WARNING Do not carry out non-invasive blood pressure measurement on patients with  sickle cell disease and skin damage or any expected damage. Do not measure NIBP on traumatic body part. This may cause further injury.
  • Page 85: Measurement Limits

    BT-770 Operation manual 11.3 Measurement limits According to the patient's condition, the oscillometric method has some limitations. This measurement is to look for the regular pulse waves generated by arterial pressure. If the patient's condition makes this detection method difficult, the measured value becomes unreliable, and pressure measurement time increases.
  • Page 86: Measurement Procedure

    BT-770 Operation manual ambient humidity 30%~85%, no condensing, ambient temperature 5~40℃, Atmospheric pressure: 700hPa~1060hPa. NIBP performance and measurement accuracy will be affected beyond the range. 11.4 Measurement procedure 11.4.1 Prepare the measurement Turn on the monitor, and check if it works properly.
  • Page 87 BT-770 Operation manual 11.4.2 Patient posture requirements during measurement Sit comfortable or lie down relaxedly. No crossing legs. Back and elbow should be supported. The center of NIBP cuff and the right atrium are at in the same level. Remind patients, no talking during measurement and try to relax.
  • Page 88: Nibp Display

    BT-770 Operation manual 11.5 NIBP display NIBP measurement has no waveform display, and only displays NIBP measurement results in the parameter area, as shown in Fig. 11-1. The figure below is for reference only. The graphics displayed on the monitor may be slightly different.
  • Page 89: Clean And Disinfection Method Of Nibp Cuff

    BT-770 Operation manual 11.8 Clean and disinfection method of NIBP cuff If necessary, NIBP cuff and NIBP extension tube can be cleaned and disinfected together without separated 11.8.1 Cleaning method Prepare enzyme cleaning agent, distilled water and 10% solvent, respectively in different spray bottle.
  • Page 90: Temp

    BT-770 Operation manual TEMP 12.1 Overview The monitor has two temperature measurement channels; the temperature sensor will measure the body temperature, and calculate the difference between the body temperature data. The monitor is designed for defibrillation proof, so the monitor operates normally after defibrillation.
  • Page 91: Measurement Requirements

    BT-770 Operation manual 12.4 Measurement requirements The normal measuring range of monitor is 0℃~50℃, and the accuracy is consistent in this range. The environmental temperature range for body temperature measuring is 5℃~40℃. Get the right temperatures for the shortest measurement time is 40s, and the measuring interval is 1s.
  • Page 92: Setting Temperature Unit

    BT-770 Operation manual 12.6 Setting temperature unit You can define your favorite temperature unit as follows: Select TEMP parameter area → “TEMP Setup” menu.  In the “TEMP Setup” menu, set “Unit” to “℃” or “℉” 12.7 Alarm setup In “TEMP Setup” menu, select “Alarm Setup >>” to enter “Alarm Setup” interface, and set TEMP alarm switch, alarm level, upper and lower alarm limit.
  • Page 93: Review

    BT-770 Operation manual Review The monitor provides up to 168 hours trend data review of all monitoring parameters, 1000 groups of NIBP measurement data and 200 physiological alarm events, 100 technical alarm events. The user can select trend chart or trend table to view trend change; or view the latest wave.
  • Page 94: Reviewing Trend Table

    BT-770 Operation manual 13.2 Reviewing trend table Select [Trend] smart hotkey to enter “Trend” menu, select “Tabular” and enter the following window. Figure 13-2: “Trend” table Browse the trend table in the following method:  Select to turn pages to left or right and move the trend table to ...
  • Page 95: Nibp Measurement Review

    BT-770 Operation manual 13.3 NIBP measurement review Select 【Trend】smart hotkey to enter “Trend” menu, and select “NIBP” to enter the following window Figure 13-3: NIBP measurement review This window shows the measurement time of noninvasive blood pressure, systolic blood pressure “SYS”, diastolic blood pressure “DIA”, mean blood pressure “MAP” and pulse rate “PR”.
  • Page 96: Battery

    BT-770 Operation manual Battery 14.1 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 an DC power source, it will charge the battery no matter whether the monitor is turned on or not. In the case of power failure, the system will automatically use the battery to power the monitor to avoid interrupting the monitor working.
  • Page 97: Battery Usage Guide

    BT-770 Operation manual 14.2 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 98: Checking Battery Performance

    BT-770 Operation manual 14.3 Checking battery performance Please refer to the following steps to check the battery performance: Disconnect the monitor from the patient and stop all monitoring or measurement.  Connect DC power to the monitor, and charge the battery for more than 4 hours ...
  • Page 99: Caring And Cleaning

    BT-770 Operation manual Caring and cleaning 15.1 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 100: Disinfection

    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 101: Maintenance

    BT-770 Operation manual Maintenance WARNING If the hospitals or institutions using this instrument can’t implement a • satisfactory maintenance schedule, it will result in device failure and may endanger human health. 16.1 Checking Check the following basic items before each using the monitor: Check for any mechanical damage.
  • Page 102: Viewing Software Version Information

    “Monitor Info” menu displays the software version information of the monitor.  16.3 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 103: Ecg Calibration

    BT-770 Operation manual 16.4 ECG calibration In the process of using the monitor, the displayed ECG signals may be inaccurate due to hardware or software problems, mainly shown as waveform amplitude becoming larger or smaller. At this moment, you need to calibrate ECG.
  • Page 104: Accessories

    BT-770 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 105: Specifications

    BT-770 Operation manual Specifications 18.1 Safety specifications 18.1.1 Product category In accordance with classification specified in the European Medical Device Directive 93/42/EEC, this monitor is Class IIb device. The monitor is classified as follows in accordance with IEC 60601-1: Category Name...
  • Page 106: Hardware Specifications

    BT-770 Operation manual 18.2 Hardware specifications Physical Characteristics Dimensions Main Unit: 320(W) X 250(H) X 65(D) Weight <= 2.8 Kg for standard configuration Display Type Color TFT touch screen LCD Size and resolution 12”, 800 X 600 pixels Audio Alarm sound (45 ~ 85 dB), key pressing sound...
  • Page 107: Functional Specification

    BT-770 Operation manual 18.3 Functional specifications 18.3.1 ECG/TEMP/RESP 3 lead I, II, III Lead Type 5 lead I, II, III, aVR, aVL, aVF, V Auto, 2.5mm/mV(x0.25), 5 mm/mV(x0.5), Display sensitivity 10mm/mV(x1.0), 20mm/mV(x2.0), 40mm/mV(x4.0) Wave sweep speed 12.5 mm/s, 25 mm/s, 50 mm/s Diagnostic mode 0.05 - 100 Hz...
  • Page 108 BT-770 Operation manual Adult: 15 ~ 300 bpm Measuring range Pediatric: 15 ~ 350 bpm Resolution 1 bpm Heart rate measurement ± 1 bpm or ± 1%, whichever is greater error Ventricular bigeminy 80 ± 1 bpm Heart rate measuring Slow alternating ventricular bigeminy 60 ±...
  • Page 109 BT-770 Operation manual RR Alarm Adult: 7 ~ 120 RR upper limit Pediatric: 7 ~ 150 Adult: 6 ~ 119 RR lower limit Pediatric: 6 ~ 149 P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd. 2018.05...
  • Page 110 BT-770 Operation manual 18.3.2 NIBP NIBP Standards compliant IEC 80601-2-30:2009/A1:2013 Measurement method Automatic oscillometric method Operating mode Manual, automatic, continuous Useful life 100, 000 times Measurement interval in 1/2/3/4/5/10/15/30/60/90/120/180/240/480min automatic mode Typical measurement 20~40s time Adult Pediatric Systolic blood pressure...
  • Page 111 BT-770 Operation manual 18.3.3 SpO Standards compliant ISO 80601-2-61:2011 Measurement accuracy verification The SpO accuracy has been verified in human experiments by Comparing with arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO- oximeter measurements.
  • Page 112: Alarm Information

    BT-770 Operation manual Alarm information This chapter lists some important physiological and technical alarm information, and some alarms are not necessarily listed. Note that in this chapter: P column indicates the default alarm priority: H indicates high priority, M indicates middle priority, L indicates low priority, and “*” indicates priority set by the user.
  • Page 113 BT-770 Operation manual Source Alarm message Causes and countermeasures ST-II Too High lower than the lower alarm limit. Check the ST-II Too Low patient’s physiological condition, and check if the ST-III Too High patient category and alarm limit settings are ST-III Too Low appropriate for the patient.
  • Page 114: Technical Alarm

    BT-770 Operation manual 19.2 Technical alarms Source Alarm message Causes and countermeasures Connect to AC power supply, and charge the battery, and power with the battery as needed System Battery Low after fully charged. ECG Comm. Stop ECG module failure, or communication failure ECG Comm.
  • Page 115 BT-770 Operation manual Source Alarm message Causes and countermeasures monitor's specifications, and check whether there are special reasons affecting ambient pressure. The measured blood pressure of the patient NIBP over range exceeds the measuring range. Patient’s pulse may be weak or cuff is too loose.
  • Page 116: Default Parameter Configuration

    BT-770 Operation manual Default parameter configuration This chapter lists the important factory default settings of different departments in monitor configuration mode. Users can not change the default configuration, but can modify the settings as required and save as user-defined configuration.
  • Page 117 BT-770 Operation manual Module defaults Module Option Adult Pediatric Alarm limits 8~30 on 8~30 on Gain Wave velocity 12.5 12.5 Wave color Yellow Yellow Wave style Line Line Alarm source Alarm level Alarm record Alarm limits 50~120 on 75~160 on...
  • Page 118: Common Faults And Maintenance

    3. Check whether the deflating valve on blood pressure plate is normal. 4. Check whether the pressure sensor is normal. If the above doesn't solve the problem, please contact Bistos after-sales department or dealers. P/N : 770-ENG-OPM-EUR-D03 Bistos Co., Ltd.
  • Page 119: 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-770 and should be kept at least 1 m away from the equipment.
  • Page 120: Electromagnetic Emissions

    BT-770 Operation manual 22.1 Electromagnetic emissions The BT-770 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-770 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The BT-770 uses RF energy only for its internal function.
  • Page 121: Recommended Separation Distances Between Portable And Mobile Rf Communications

    22.2 Recommended separation distances between portable and mobile RF communications equipment and BT-770 The BT-770 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the BT-770 can help prevent...
  • Page 122: Electromagnetic Immunity

    BT-770 Operation manual 22.3 Electromagnetic immunity The BT-770 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-770 should assure that it is used in such an environment. IEC 60601 Electromagnetic Immunity test...
  • Page 123 BT-770 Operation manual The BT-770 is intended for use in the electromagnetic environment specified below. The customer or the user of the BT-770 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
  • Page 124: Product Warranty

    Sales Agency Manufacture Bistos Co., Ltd. ※ Thank you for purchasing BT-770. ※ 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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