Bistos BT-770 Operation Manual Download Page 107

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BT-770 Operation manual

106

P/N : 770-ENG-OPM-EUR-D03

Bistos Co., Ltd.

2018.05

18.3 Functional specifications

18.3.1 ECG/TEMP/RESP

ECG

Lead Type

3 lead

I, II, III

5 lead

I, II, III, aVR, aVL, aVF, V

Display sensitivity

Auto, 2.5mm/mV(x0.25), 5 mm/mV(x0.5),

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

Band width

Diagnostic mode

0.05 - 100 Hz

Monitor mode

0.5 - 40 Hz

Surgery mode

1 - 25 Hz

CMRR

>100 dB

Notch

50/60 Hz notch filter can be set to on or off

Differential input

impedance

> 5 MΩ

Electrode polarization

voltage range

± 400 mV

Baseline recovery time

<5s after defibrillation (in monitor and surgery mode)

Calibration signal

1 mV (peak – peak), accuracy ± 3%

Lead-off detection

current

Measuring electrode: < 0.1 uA

Drive electrode: < 1uA

Pacing pulse

Pulse identification

For PACE MAKER pulses that meet the criteria below, pacing

pulse will be marked on the screen.

Detection range(Amplitude): ± 2 mV ~ ± 700 mV

Pulse width: 0.2ms ~ 2.0 ms

Average HR

Calculate from 15s data

Interval of HR refreshing

Calculate once every second

HR change response time Time from 80 bpm to 120 bpm: ≤ 10 sec

Time from 80 bpm to 40 bpm: ≤ 10 sec

Tall T-wave suppression

For T-wave with 100ms QRS wave, 350ms QT period, 180ms

duration and 1.2mV amplitude, the HR calculation will not be

affected

Without overshoot

rejection of pacemaker

pulses

Amplitudes (ap) from ±2 mV to ±700 mV and pulse widths

from 0.1 ms to 2.0 ms.

Tall T-wave rejection

capability

2mV

Summary of Contents for 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: ...ver 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 The information contained herein is subjects to change without notice Prepared by Bistos Co Ltd 7 th FL A Bldg Woolim Lions Valley 5 cha 302 Galmachi ...

Page 3: ... 8 Essential performance 28 2 Preparing for operation 29 2 1 Installation 29 2 2 Connecting to power 31 3 Basic operations 32 3 1 Turn on 32 3 2 Turn off 33 3 3 Basic operations 33 3 4 Operation mode 36 3 5 Measurement setup 36 3 6 Freezing waves 37 3 7 Other common setup 37 4 Patient information management 41 4 1 Patient setup menu 41 4 2 Admitting a patient 42 4 3 Patient information 43 4 4 Disc...

Page 4: ...Respiration display 71 8 5 Respiration setup 72 8 6 Alarm setup 73 9 PR 74 9 1 Overview 74 9 2 Display 74 9 3 Setting PR sound 74 9 4 Alarm setup 74 10 SpO2 75 10 1 Overview 75 10 2 Safety information 75 10 3 Monitoring steps 77 10 4 Display 78 10 5 Setting SpO2 79 10 6 Measuring influencing factors 80 10 7 Alarm setup 80 10 8 Technical description 81 11 NIBP 82 11 1 Overview 82 11 2 Safety inform...

Page 5: ...leaning 98 15 1 Overview 98 15 2 Cleaning 98 15 3 Disinfection 99 16 Maintenance 100 16 1 Checking 100 16 2 Viewing software version information 101 16 3 Maintenance plan 101 16 4 ECG calibration 102 17 Accessories 103 18 Specifications 104 18 1 Safety specification 104 18 2 Hardware specifications 105 18 3 Functional specification 106 19 Alarm information 111 19 1 Physiological alarm 111 19 2 Tec...

Page 6: ...7 Lead full screen format 49 Figure 7 1 3 Lead placement method 63 Figure 7 2 5 Lead placement method 64 Figure 7 3 ECG wave in standard display format 66 Figure 7 4 ECG parameter in standard display format 66 Figure 7 5 ECG Setup menu 67 Figure 8 1 5 lead respiration electrode placement 70 Figure 8 2 Respiration wave 71 Figure 8 3 Respiration parameter display 71 Figure 8 4 RESP setup menu 72 Fig...

Page 7: ...and this manual in order to stand for the information about Used to identify safety information Be well known this information thoroughly before using BT 770 Used to identify safety information Be well known this information thoroughly before using BT 770 IPX1 Indicates the protection level against the ingress of liquid IPX1 is protection against some water drops falling vertically It correspond t...

Page 8: ...ates a defibrillation proof type CF applied part Indicates CLASS II equipment Adapter 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 Indicates the temperature limitation for operation transport and s...

Page 9: ...tes 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: ...e schedule it will result in device failure and may endanger the patient s safety Use the patient monitor under the conditions specified in this operation manual 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...

Page 11: ...trument The physiological wave physiological parameters and alarm information displayed on the monitor are only for the doctor s reference and should not be directly used as the basis for clinical treatment This is not a therapeutic device For patients with pacemakers the cardio tachometer may count the pacemaker pulse in case of a cardiac arrest or arrhythmias Never rely solely on the cardio tach...

Page 12: ...al force Avoid instrument splashed by water Avoid high temperatures the instrument should be used within a temperature range of 5 40 Avoid using instrument in the environment such as pressure is too high poor ventilation dusty or contain salt sulfur gas and chemical Before using the monitor check the monitor and accessories if there is damage that may affect patient safety If there is obvious dama...

Page 13: ...eed in such a case 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 Ensure that the conductive parts of electrodes and associated connectors...

Page 14: ...ctive dust or dirt Do not allow cleaning agents to contact electrical components and do not spray cleaning solutions onto any of these surfaces Personal injury or equipment damage could occur Do not expose the unit to excessive moisture that would allow for liquid pooling Personal injury or equipment damage could occur Do not touch the patient and signal input output parts simultaneously Due to th...

Page 15: ...necting the battery with polarity Do not use the battery near fire or environmental temperature exceeds 60 Do not heat or splash the battery or throw it into fire or water Do not destroy the battery Do not pierce battery with a sharp object such as a needle Do not hit with a hammer step on or throw or drop the battery Do not disassemble or modify the battery The battery can heat smoke deformation ...

Page 16: ...es from 5 40 Operating humidity ranges from 30 85 Avoid in the vicinity of electric heater Avoid placing in an area where there is an excessive humidity rise or ventilation problem Avoid placing in an area where there is an excessive shock or vibration Avoid placing in an area where chemicals are stored or where there is in danger of gas leakage Avoid dust and especially metal material enter into ...

Page 17: ...70 patient monitors 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 1 Intended patient population Pediatrics 30 days and 18 years and adult 18 years adults 2 Intended user profile Doctor physicians or nursing staff who is qualified personnel Basic experiences or knowledge on ...

Page 18: ...d pressure NIBP Indication To determine a patient s blood pressure Screen for hypertension Following the effect of anti hypertensive treatments in a patient to optimize their management Assessing a person s suitability for a spot or certain occupations Estimation of cardiovascular risk Determining for the risk of various medical procedure Figuring out whether a patient is clinically deteriorating ...

Page 19: ...otherapy as the evaluation of primary and secondary cardiomyopathic processes among others Contraindications No absolute contraindications to performing an ECG exist other than patient refusal Some patients may have allergies or more commonly sensitivities to the adhesive used to affix the leads in these cases hypoallergenic alternatives are available from various manufacturers Source Tarek A Elec...

Page 20: ...m 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 Temperature probe AC DC adapter Options of BT 770 External plug in printer ...

Page 21: ... for ECG measurement 1ea Adult SpO2 sensor standard SpO2 sensor for adult 1ea SpO2 extension cord Standard Cord to connect the SpO2 sensor and main body 1ea Adult NIBP cuff standard Measures NIBP for adult 1ea NIBP extension tube standard Tube to connect the NIBP cuff and main body 1ea Temperature sensor Standard Measures the body temperature 1ea Adapter Standard For power supply 1ea ...

Page 22: ...BT 770 Operation manual 21 P N 770 ENG OPM EUR D03 Bistos Co Ltd 2018 05 1 4 Product outlook Figure1 1 Front view Figure1 2 Side view ...

Page 23: ...BT 770 Operation manual 22 P N 770 ENG OPM EUR D03 Bistos Co Ltd 2018 05 Figure1 3 Rear view ...

Page 24: ... priority Yellow constant on 2 Display area Display the waveform and measured value 3 Power Power On Press down the key more than 2 seconds 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 4 Battery indicator On The battery is being charged or has been fully charged Off The battery has not been installed Flashing Th...

Page 25: ... 5 10 15 minutes and permanent Default setting is 2 minutes 8 NIBP start stop Start and stop the non invasive blood pressure measurement 9 Control knob Rotate move the cursor Press select the menu or execute a command 10 Setting Enter to the setting mode Press again to close the setting mode 11 Freeze Freeze unfreeze the waveform Figure1 5 Side view ...

Page 26: ...rface 2 T2 Temperature probe interface 3 SpO2 SpO2 cable interface 4 ECG ECG cable interface 5 NIBP NIBP cuff interface Figure1 6 Rear view Name Description 1 Handle Handle for main body transport 2 Speaker holes For alarm and synchronizing sound 3 Air outlet Heat dissipation 4 Battery cover Battery compartment cover ...

Page 27: ...o Ltd 2018 05 5 Bracket To wall mount the monitor 6 ID label Identify the monitor information 7 Air intake For ventilation 8 Auxiliary output interface Nurse call 9 Network port For CMS 10 USB port For trend or software upgrade 11 Power adapter 15V 2 4A adapter ...

Page 28: ...th name of the parameter on the left side 3 Parameter area Show the corresponding parameter measured value and current upper and lower alarm limits of each parameter module The parameters are shown in fixed position that is from top to bottom and from left to right ECG NIBP SpO2 and PR TEMP RESP 4 Information Tip Area Display the network status battery status automatic identification screen bright...

Page 29: ... key 1 8 Essential performance This device Multi parameter Patient Monitor provides various patient vital signs such as pulse rate ECG respiration blood oxygen saturation blood pressure and temperature by placing or inserting the various sensors to the appropriate site of patient The device is composed with display control circuit and panel and input part for various sensors It detects ECG SpO2 NI...

Page 30: ... organization or individual shall not interpolate copy or exchange by any means or form When the monitor is combined with other devices it must comply with IEC 60601 1 2005 A1 2012 and should not be connected with multiple socket outlet or extension cord Do not connect the device on other equipment or network to which a signal input output part may be connected Prior to installation the operator m...

Page 31: ... Transportation Prevent severe shock vibration rain and snow splashing during transport Storage The packaged monitor should be stored in well ventilated room with ambient temperature 20 60 relative humidity 0 95 Non condensing atmospheric pressure 700 1060 mbar hPa and without corrosive gases The operating environment of the monitor should avoid noise vibration dust corrosive or flammable and expl...

Page 32: ...ect 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 Use the power adapter provided with the monitor Plug the power adapter into the power connector of the monitor and plug the other end of the power adapter into the mains low voltage power supply network facilities power outlet with protective ear...

Page 33: ...ately 3 1 2 Start the monitor If finish to check the monitor it is ready to start the monitor Press the Power key the yellow warning lights flash once and the system enter the program reading interface finally the system makes a tick sound the boot screen disappears and the system enters the main interface If any fatal error occurs during self test the system will alarm If this case persists pleas...

Page 34: ... and hold the Power key for 2 seconds to pop up the 3 seconds countdown window and the monitor turns off in 3 seconds CAUTION If the monitor is not turned off properly you can simply disconnect the power to shutdown forcibly But the forced shutdown may cause data loss and it is not recommended 3 3 Basic operations 3 3 1 Using the control knob Control knob can be used to perform the following opera...

Page 35: ...n operate quickly are displayed at bottom of the screen Refer to 1 7 Smart Hotkeys Hard keys The physical keys on the monitor such as the Alarm pause key on the front panel Popup keys Menu keys relevant to the tasks that automatically appear on the monitor screen when need such as the confirmation key popped up when you need to confirm the change 3 3 3 Using the touch screen Click on the touch scr...

Page 36: ...ly similar to the Settings and generally consists of the following components Menu title A title of the current menu Close menu Close the current menu Exit the current menu or close the current menu and return to the previous menu Main display area Display options buttons or prompt messages The symbol indicates that selecting this option can enter the corresponding submenu Confirmation key area So...

Page 37: ... the monitor enters the demo mode Exit demo mode Select Settings Smart Hotkey or press Setting key on the monitor panel Settings Select Exit Demo and the monitor exits the demo mode WARNING The demo mode is mainly used to show the monitor s performance and for user training In actual clinical use the demo function is prohibited in order to avoid mistaking the displayed waves and parameters as thos...

Page 38: ...up of the monitor is the general setup that defines how the monitor works for example alarm volume setting They may affect the setup of multiple measurements or display interfaces 3 7 1 Defining the monitor When install the monitor or change the usage occasion the monitor should be defined as follows Select Settings Smart Hotkey or press Setting key on the monitor panel Settings Select User Mainte...

Page 39: ...e monitor is Spanish Français The interface language of the monitor is French 3 7 3 Date and time Set the monitor time 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 menu Select Time Setup enter Time Setup menu Or you can enter the Time Setup directly by touching the time...

Page 40: ...off 4 Touch Volume Select Volume smart hotkey Volume Setup menu Select Touch Volume Set touch volume from 0 to 9 0 means off 5 Key Volume Select Volume smart hotkey Volume Setup menu Select Key Volume Set key volume from 0 to 9 0 means off 3 7 5 Setting parameter unit You can select a preferred unit through the following operations Select Settings Smart Hotkey or press Setting key on the monitor p...

Page 41: ...Operation manual 40 P N 770 ENG OPM EUR D03 Bistos Co Ltd 2018 05 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 ...

Page 42: ...o Patient Type and Pace Maker Patient Type default Adult Pace Maker default No and the user must confirm that the default value is appropriate for the patient being monitored For patients with pacemakers Pace Maker must be set to Yes Otherwise the pacing pulse will be treated as normal QRS wave group and the system is unable to detect the alarm status of ECG Signal weak For patients without a pace...

Page 43: ...dmit 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 and Pediatric Select Pace Maker and set whether the patient wears a pacemaker according to the patient condition Yes or No After setting select OK to save the current setup or select Cancel and do not save the current setup ...

Page 44: ... Letters not more than 20 characters 2 Select First Name and enter patient name through the soft keyboard Letters not more than 20 characters 3 Select Patient ID and enter the patient ID through the soft keyboard Letters not more than 20 characters 4 Select Case Number and enter the case number through the soft keyboard Letters not more than 20 characters 5 Select Gender and set the patient s gend...

Page 45: ...atient menu select Discharge Patient Warning message OK to finish the operation of discharging a patient After the patient is discharged all the information of the patient stored in the monitor will be cleared Therefore discharge the patient only when needed 4 5 Clear alarms To clear alarms operate as follows In the Patient menu select Clear Alarms Warning message OK to finish the operation of cle...

Page 46: ... 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 Therefore clear NIBP trend only when needed ...

Page 47: ...creen The user can select the display format according to needs and get different screen information 5 1 Selecting user interface Select the user interface as follows Select Displays smart hotkey Screen Select Select the display format according to needs Normal Screen Standard interface Big ECG Screen Big ECG interface Big font Screen Big font interface ECG 7 Lead Full Screen ECG 7 Lead Full inter...

Page 48: ...ay 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 5 2 2 Big ECG format The big ECG format is as shown in Figure 5 2 ...

Page 49: ...BT 770 Operation manual 48 P N 770 ENG OPM EUR D03 Bistos Co Ltd 2018 05 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 ...

Page 50: ...70 Operation manual 49 P N 770 ENG OPM EUR D03 Bistos Co Ltd 2018 05 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 ...

Page 51: ...information of physiological alarm is displayed in the physiological alarm area on top of the screen Technical alarms Technical alarm is also known as a system error message which is caused by improper operation or system failure resulting in system malfunction or monitoring result distorted The information of technical alarm is displayed in the technical alarm area on top of the screen Prompt mes...

Page 52: ...s and some physiological alarms have been set in the monitor at the factory and cannot be modified by the user The levels of some physiological alarms can be modified 6 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 dist...

Page 53: ...ystem will distinguish the alarm priority with different background colors High priority alarm Red Medium priority alarm Yellow Low priority alarm Yellow The following flags in front of physiological alarms are used to distinguish the alarm priorities High priority alarm Medium priority alarm Low priority alarm 6 3 4 Parameter flashing When the physiological parameter values in the parameter area ...

Page 54: ...plays the icon When a new physiological alarm or technical alarm occurs the alarm reset is automatically canceled 6 4 2 Alarm sound off The alarm sound can be turned off through the following operations Select Settings smart hotkey Settings Select User Maintenance enter the password and confirm User Maintenance menu Select Alarm Param Alarm Param menu Set Minimum Alarm Volume to 0 Minimum Alarm Vo...

Page 55: ...hnical alarms are suspended but the alarm message is still displayed After the alarm pause is finished the monitor will automatically cancel the alarm pause state During the alarm pause you can also press Pause smart hotkey or Alarm pause key on the monitor panel to cancel the alarm pause manually You can set the alarm pause time as follows Select Settings Smart Hotkey or press Setting key on the ...

Page 56: ...se state Pause smart hotkey will appear magnified icon The physiological alarm area displays Alarm Pause You can press the Pause smart hotkey again to manually cancel the alarm off If the monitor is in the alarm state of suspension or high priority technical alarm is triggered the alarm and the alarm off pause are automatically canceled WARNING When the alarm volume is set to 0 or the alarm pause ...

Page 57: ...s 6s 7s 8s Alarm delay time is 1 sec 2 sec 3 sec 4 sec 5 sec 6 sec 7 sec or 8 sec By default the alarm delay time is 4 seconds Select ST Alarm Delay and set the ST alarm delay time as needed Off ST alarm delay is off 10s 20s 30s 45s 1min 2min 3min ST alarm delay time is 10 sec 20 sec 30 sec 45 sec 1 min 2 min or 3 min By default the ST alarm delay time is 20 seconds 6 5 2 Setting the alarm reminde...

Page 58: ...e monitor will prompt according to the set alarm level Off Turn off SpO2 alarm icon is displayed in the parameter area and the monitor won t prompt the parameter alarm 2 Set the alarm priority Select Alarm Level and set the alarm priority as follows Mid Set the alarm priority to medium High Set the alarm priority to high Note Regulatory requirements the parameter ECG blood oxygen saturation blood ...

Page 59: ...arms can be set to Latching or No latching Latching Even if the cause of physiological alarm is cleared the system will still be latched that is continue to display the alarm information corresponding to physiological alarm the alarm sound also continues but the alarm mode has the following changes Parameters and upper or lower alarm limit are no longer flashing Display the time that the latest al...

Page 60: ...ly record these events through the Event smart hotkey and then view it in the event review refer to15 4 Event Review for detailed operation 6 8 Alarm record When the monitor s machine alarm system is powered down all alarm records are not saved Physiological alarm can store 200 alarm records if full of 200 the latest alarm records will replace the beginning of the record Technical alarm can store ...

Page 61: ...ected to the monitor ECG electrodes connected to the patient Connect to the monitor with five lead ECG cable and ECG can display two different waves by adjusting the two leads You can use the control knob to change the lead name on the left of the ECG wave on the screen and select the lead to be monitored The parameters displayed in the parameter area of the monitor include heart rate HR ST segmen...

Page 62: ... analysis must be turned on Otherwise the pacing pulse may be counted as a normal QRS wave make the ECG signal too weak to detect the alarm Periodically check the skin that the electrode is placed at If there is any sign of allergy or irritation replace the electrode or change the placement position Electrosurgical ESU device interference defibrillator discharge When the patient needs defibrillati...

Page 63: ...cement to remove dead skin cells Wash the skin thoroughly with soap and water do not use ether and pure alcohol as this will increase the skin s impedance Dry the skin completely before placing the electrode Install the spring clip or stud prior to the placement of the electrodes Place the electrode on the patient Connect the ECG cable and ECG interface WARNING Check if the lead is adequately atta...

Page 64: ...andard and American Standard European Standard EN American Standard AHA Lead Name Color Lead Name Color R Red RA White L Yellow LA Black F Green LL Red N Black RL Green C White V Brown 7 3 4 Installing the electrodes 3 lead The electrode placement position of 3 lead is shown in Fig 7 1 R RA electrode placed below the clavicle near the right shoulder L LA electrode placed below the clavicle near th...

Page 65: ...oulder N RL electrode placed on the right abdomen F LL electrode placed on the left abdomen C V electrode placed on the chest wall European Standard American Standard Figure 7 2 5 Lead placement method NOTE To ensure the patient safety all leads must be connected to the patient If the electrodes are attached correctly but the ECG wave is not accurate then replace the lead Interference from ungroun...

Page 66: ...g state in the following method Select the patient information area to pop up the Patient Info menu or select the Pat Sat smart hotkey and select Patient Info menu Select Yes No for Pace Maker as needed indicating that the patient with or without pacemaker Diagnostic Monitor Surgery will not affect rejection of pacemaker pulses WARNING For patients with pacemakers the cardio tachometer may count t...

Page 67: ...s for reference purposes only The graphics displayed on your monitor may be slightly different Figure 7 3 ECG wave in normal display format In addition when Pace Maker is set to Yes and the patient wears a pacemaker the symbol will be marked in the top of the ECG wave ECG parameter display The ECG parameter area of the monitor in the normal screen is shown in Fig 9 4 Figure 7 4 ECG parameter in st...

Page 68: ...onitoring as the HR source Select Calculated Channel and select heart rate calculated channel Auto Automatically select Heart Rate calculated Channel I Select the first ECG waveform as the Heart Rate calculated Channel II Select the second ECG waveform as the Heart Rate calculated Channel V Select the third ECG waveform as the Heart Rate calculated Channel Select ECG1 ECG2 to set the display wave ...

Page 69: ... is 25mm s Select Filter and set the filter mode Diagnostic Diagnostic mode Monitor Monitor mode Surgery Surgery mode Select Arrhythmia Analysis and set the alarm switch alarm level alarm record Select ST Analysis and set the ST analysis ST Channel ST Alarm Setup ST analysis You can set Off or On ST Channel You can set 1 2 3 ST Alarm Setup and set the alarm switch alarm level alarm record Select O...

Page 70: ...measuring the changing impedance value The monitor calculates the respiration rate RR according to the wave cycle 8 2 Safety information NOTE Respiration monitoring does not apply to patient with large range of activities as this may lead to false alarm WARNING Do not use anti electric knife ECG cable for respiration monitoring Respiration measurement cannot identify the apnea because it will alar...

Page 71: ...m and L left arm electrodes of I lead or R right arm and F left leg electrode of II lead NOTE For optimal respiration wave R and L electrodes should be placed horizontally if I lead is selected for respiration measurement R and F electrodes should be places diagonally if II lead is selected for respiration measurement Figure 8 1 below shows the placement of 5 lead electrodes Figure 8 1 5 lead resp...

Page 72: ...aused 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 8 4 Respiration display Respiration wave is displayed as shown in Figure 8 2 Figure 8 2 Respiration wave Respiration parameters are displayed as sho...

Page 73: ...opriate value and set the apnea alarm time When the apnea time of the patient is longer than the set time the monitor will trigger an alarm Set time can be set 20s 25s 30s 35s 40s 45s 50s 55s 60s default apnea alarm time is 20s 8 5 2 Adjusting wave gain In RESP Setup menu select Wave Gain and set the wave gain the greater gain the higher wave amplitude Gain can be set x0 5 x1 x2 the default is x1 ...

Page 74: ... 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 4 5 The default is 2 8 6 Alarm setup Select Alarm Setup Alarm Setup interface to set respiration related alarms see 6 5 Alarm Setup for the setting method ...

Page 75: ...s SpO2 parameter color of PR source as shown in Fig 9 1 Figure 9 1 PR parameter display 9 3 Setting PR sound Select SpO2 parameter area or SpO2 wave area SpO2 Setup menu Select Pulse Volume to set Pulse Volume to 0 9 Select 0 to turn off the pulse volume and select 9 to set the maximum volume NOTE HR sound has higher priority than PR sound When HR makes a sound PR won t When HR sound set to 0 PR c...

Page 76: ...tion pulsation can give a plethysmography wave and pulse rate signal The main screen displays SpO2 value and plethysmography wave This monitor applies to measure SpO2 of adults 18 years and pediatric 18 years 30 days Contact SpO2 probe to Patient s finger or toe to get SpO2 value and plethysmography wave SpO2 function of this monitor has been calibrated in factory The monitor is defibrillation pro...

Page 77: ...pection such as patients with perfusion disorders or sensitive skin because persistent and prolonged monitoring may increase unpredictable skin changes such as allergies redness blistering or pressure necrosis When the measured pulse rate is not complete then the Before using verify compatibility between the monitor probe and cable otherwise it may cause injury to the patient Functional testers ca...

Page 78: ...e on the patient s body 5 Select the appropriate alarm settings 6 Start monitoring NOTE Turn on the monitor plug in SpO2 probe and connect patient s finger or toe monitor displays SpO2 wave SpO2 Pulse Search displayed in the technical alarm area until the monitor measured SpO2 value and pulse rate SpO2 Search Timeout displayed in the technical alarm area until the monitor measured pulse rate Check...

Page 79: ...tion manual 78 P N 770 ENG OPM EUR D03 Bistos Co Ltd 2018 05 10 4 Display SpO2 parameter area is as shown in figure 10 1 Figure 10 1 SpO2 parameter display SpO2 wave is as shown in figure 10 2 Figure 10 2 SpO2 wave ...

Page 80: ...tting wave speed Select Wave Speed and set wave speed to 12 5mm s or 25mm s the faster speed the smoother wave 10 5 2 Setting wave mode Select Wave Mode and set the wave drawing mode Scan Scan mode Fill Fill mode 10 5 3 Setting average time Select Average Time and set the average time to 2 4s 4 8s 8 16s 10 5 4 Pulse volume The user can set the pulse volume The pulse volume can be set to 0 1 2 3 4 ...

Page 81: ...emoglobin COHb and methemoglobin MetHb Shock anemia hypothermia and the application of vasoconstrictor drugs may reduce the arterial blood flow to a level that cannot be measured The measurement also depends on the absorption of specific wavelengths of light by oxyhemoglobin and reduced hemoglobin If there is any other substance that absorbs the same wavelength the measurement may have false or lo...

Page 82: ... 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 Functional testers cannot be used to evaluate the accuracy of pulse oximetry probe and pulse oximetry Measure the maximum temperature between the oxygen probe and the tissue contact surface Measured as described in Annex BB of ISO 80601 2 61 ...

Page 83: ...d pressure Manual mode Using Manual mode start to measures by hand Automatic mode measures Use manual mode to open automatic mode then the measure will automatically turn to automatic mode after a certain time During measurement any error will stop the current automatic measurement but not affect next automatic measurement unless the time interval less than 30s If the time interval less than 30s s...

Page 84: ...amage around the duct when the cuff is inflated and makes the infusion slow down or be blocked The inflatable tube connecting the blood pressure cuff and the monitor should be smooth without entanglement The pressure generated by being kinked connection tubing may cause blood flow interference For patients with severe thrombotic disorders determine whether to carry out automatic blood pressure mea...

Page 85: ...hows arrhythmia which results in irregular heartbeat the measurement will be unreliable and even cannot be done and the pressure measurement time will be extended Use of an artificial heart lung machine If a patient is connected to an artificial heart lung machine the measurement will be impossible Pressure changes If the arterial pressure pulse is being analyzed to obtain a measured value at a ce...

Page 86: ...ressure cuff extension tube to the monitor 4 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 Select the appropriate cuff marked with appropriate limb circumference Cuff width should be 40 of the limb circumference or 2 3 of the upper arm le...

Page 87: ...n where he she can readily operate the sphygmomanometer 11 4 3 Start stop measurement Use the NIBP start stop key on the monitor panel or NIBP smart hotkey on the display to start stop the blood pressure measurement 11 4 4 Correcting measurement results The position of limb blood pressure measurement should be in the same horizontal position of the patient s heart Otherwise correct the measurement...

Page 88: ... Setup menu Select Initial Pressure and set the appropriate cuff pressure value When the patient is adult the pressure can be select from 140 160 180 The default cuff pressure value is 160 Select Initial pressure and set the appropriate cuff pressure value When the patient is pediatric the pressure can be select from 140 160 The default cuff pressure value is 140 11 7 NIBP reset Select NIBP parame...

Page 89: ... Rinsed with copious amounts of distilled water NOTE Please be especially careful to clean the air ball and control valve of whole air system Do not allow any liquid entering into reversing valve and saturated valve Don t use a soft cotton ball and fiber to clean this accessory because they will stick on the cuff and extension tube 11 8 2 Disinfection method 1 Sprinkle bleach solution Formula the ...

Page 90: ... Sensor Off and TEMP2 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 12 3 Measurement steps Please refer to the following steps 1 Turn on the monitor and check if it works normally 2 Select the appropriate temperature probe according to the ...

Page 91: ...emperature of two channels T1 and T2 and the alarm limits difference between the two temperature TD and temperature units Select Temp parameter area and open the Temp Setup menu Temperature display area is as shown below Figure 12 1 TEMP parameter display WARNING The operator prior to use need to check the compatibility of the probe and thermometer If the temperature value displayed by the monitor...

Page 92: ...ter 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 See 6 5 Alarm Setup for detailed setting method 12 8 Technical description Accessories have passed the biocompatibility test and meet the requirements of ISO 10993 1 ...

Page 93: ... following window Figure 13 1 Trend chart In the trend chart use the following method to select the parameter to be reviewed Select the parameter box rotate the shuttle to select the parameters to be reviewed press the shuttle and set the parameter box as the parameter to be reviewed Browse the trend chart in the following method Select and to move the trend cursor Select and to turn pages to left...

Page 94: ...tkey 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 and to turn pages to left or right and move the trend table to observe the target parameters Select and to turn pages up or down and move the trend table to observe more data ...

Page 95: ...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 The monitor can store 1000 sets of NIBP measurements in total NIBP viewing method is as follows Select and to turn pages up or down and move the trend table to observe more data ...

Page 96: ...e the battery to power the monitor to avoid interrupting the monitor working The battery icon on the screen indicates the battery status Battery is working properly and is fully charged Battery is working properly and the green part indicates the battery power Battery power is low and requires charging immediately or else the pulse oximeter will turn off automatically Battery is not installed Batt...

Page 97: ...re servicing the monitor or you suspect that the battery is the fault source also check the battery performance WARNING Keep the battery out of the reach of children Use only the designated battery If the battery is damaged or leaks replace it immediately Do not use a defective battery for the monitor Do not open the battery compartment Only the qualified service personnel authorized by the manufa...

Page 98: ... the time stated in specifications please contact our service personnel for replacing the battery WARNING Do not open the battery compartment Only the qualified service personnel authorized by the manufacturer can open the battery compartment and replace or check the battery and when it needs replacement the replacement should be same model with established battery 14 4 Battery recycling If the ba...

Page 99: ...uency of cleaning Before cleaning please consult the hospital about device cleaning requirements Below are available cleaning agents Diluted ammonia Diluted sodium hypochlorite washing bleach Diluted formaldehyde Hydrogen peroxide 3 Ethanol 70 Isopropanol 70 Before cleaning Turn off the monitor and disconnect the power Use a soft cotton ball to adsorb appropriate amount of cleaning agent and wipe ...

Page 100: ... any part of the device into liquid Do not leave any cleaning solution on the surface of any part of the device NOTE 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 hospita...

Page 101: ...6 12 months or after each repair a comprehensive examination must be performed by trained and qualified technical service personnel including functional safety checks the specific inspection items are as follows Environment and power meet the requirements Device and accessories have no mechanical damage The power supply has no wear and the insulation is good Specified accessories are used Alarm sy...

Page 102: ...of Bistos When the following maintenance is needed please contact your service representative Before testing or maintenance clean and disinfect the device Inspection Maintenance Item Frequency Check the safety according to IEC 60601 1 At least once every two years after replacing the power supply or the monitor falls down Check all monitoring or measuring functions not listed At least once every t...

Page 103: ...s follows Connect the ECG cable to the monitor Connect the ECG electrodes to the ECG simulator Select Settings Smart Hotkey Settings Menu Select User Maintenance enter the password and confirm User Maintenance menu Select Module Maintenance Module Maintenance menu Select ECG ECG Maintenance menu and select Calibration to calibrate the ECG Measure the wave amplitude with a caliper in different filt...

Page 104: ... Cables SpO2 Sensor Blood Pressure Cuff and Temperature Sensor the normal life time is two years Please replace in time Standard accessories are as follows No Description QTY Type number 1 ECG Cables and lead wires ECG electrodes 5 1 Manufacturer Shenzhen Launch Electronics Tech CO Ltd 98ME01AC009 AHA standard or 98ME01EC009 IEC standard 2 Adult Finger Clip SpO2 Sensor 1 Manufacturer Unimed Medica...

Page 105: ...d equipment When you question the integrity of the external protective earthing or protective ground conductor parameter of the equipment the device must be powered by the internal power supply battery Electric shock protection grade Type CF applied part defibrillation proof Explosion protection grade Common equipment no explosion protection Liquid inlet protection grade IPX1 Operating mode Contin...

Page 106: ...eet the IEC 60601 1 8 standard requirements Alarm signal Alarm delay Off 1s 2s 3s 4s 5s 6s 7s 8s depending on the setup Default is 4s Pause duration 1min 2min 3min 4min 5min 10min 15min or permanent depending on the setup Default is 2 minutes Data storage Trend 168 hours Resolution 1 min Alarm event 200 physiological alarm events 100 technical alarm events NIBP measurement result 1000 groups Envir...

Page 107: ... surgery mode Calibration signal 1 mV peak peak accuracy 3 Lead off detection current Measuring electrode 0 1 uA Drive electrode 1uA Pacing pulse Pulse identification For PACE MAKER pulses that meet the criteria below pacing pulse will be marked on the screen Detection range Amplitude 2 mV 700 mV Pulse width 0 2ms 2 0 ms Average HR Calculate from 15s data Interval of HR refreshing Calculate once e...

Page 108: ...5 s 1 mV 195 bpm Ventricular tachycardia 5 s 4 mV 195 bpm Ventricular tachycardia 5 s HR Alarm HR upper limit Adult 16 300 1 bpm step Pediatric 16 350 1 bpm step HR lower limit Adult 15 299 1 bpm step Pediatric 15 349 1 bpm step TEMP Standard compliance ISO 80601 2 56 2009 Measurement method Thermistor Operating mode Direct mode Measuring range 0 50 0 32 122 0 Resolution 0 1 Measurement accuracy 0...

Page 109: ...BT 770 Operation manual 108 P N 770 ENG OPM EUR D03 Bistos Co Ltd 2018 05 RR Alarm RR upper limit Adult 7 120 Pediatric 7 150 RR lower limit Adult 6 119 Pediatric 6 149 ...

Page 110: ...e error 5mmHg Maximum standard deviation 8mmHg Resolution 1mmHg Initial inflation pressure Default Pressure setting range Adult 160mmHg 140mmHg 160mmHg 180mmHg Pediatric 140mmHg 140mmHg 160mmHg Overpressure protection point software Adult 300mmHg Pediatric 240mmHg Overpressure protection point hardware Adult 320 330mmHg Pediatric 265 275mmHg Static Pressure accuracy 3mmHg NIBP Alarm Adult Pediatri...

Page 111: ...ects light skin are 5 subjects dark skin are 3 subjects the age from 21 to 28 Overall accuracy was determined by calculating the root mean square error across all samples and is 1 56 Display range 0 100 SpO2 display resolution 1 SaO2 checking accuracy 2 70 100 not define when lower than 70 SpO2 alarm limit range Upper alarm limit 1 100 Lower alarm limit 0 99 SpO2 alerting signal generates a delay ...

Page 112: ... lower alarm limit Check the patient s physiological condition and check if the patient category and alarm limit settings are appropriate for the patient HR Too Low PVCS Too High M PVCs value is higher than the upper alarm limit or lower than the lower alarm limit Check the patient s physiological condition and check if the patient category and alarm limit settings are appropriate for the patient ...

Page 113: ...the patient category and alarm limit settings are appropriate for the patient T1 Too Low T2 Too High T2 Too Low TD Too High TD value is higher than the upper alarm limit or lower than the lower alarm limit Check the patient s physiological condition and check if the patient category and alarm limit settings are appropriate for the patient SpO2 SpO2 Too High M SpO2 value is higher than the upper al...

Page 114: ...patient or monitor malfunctions or sensor other than specified in this Manual is used Check the sensor mounting position whether the sensor is damaged or sensor type Reconnect the sensor or use new sensor SpO2 Sensor Off L SpO2 Search Timeout L SpO2 Search Pulse L Sensor signal is poor or too weak Check the patient s condition and place the sensor in a suitable position If the failure persists rep...

Page 115: ... too loose Check the condition of the patient and place the cuff in a suitable position If the failure persists replace the cuff NIBP signal unstable L Excessive movement may result in too much motion artifact or interference in the signal during measurement NIBP signal saturated L Motion signal amplitude is too large due to movement and other reasons NIBP over pressure L Cuff overpressure and gas...

Page 116: ...s 0 2 0 2 on 0 2 0 2 on Arrhythmia analysis Alarm level Mid Mid Alarm record Off Off Alarm limits 0 10 on 0 10 on ARR alarm settings Alarm switch On On Alarm level Mid Mid Alarm record Off Off Gain x1 x1 Wave velocity 25 0mm s 25 0mm s Filter mode Monitor Monitor Wave color Green Green Wave style Color scale Color scale NIBP Alarm level Mid Mid Alarm record Off Off Pressure unit mmHg mmHg Measurem...

Page 117: ...city 12 5 12 5 Wave color Yellow Yellow Wave style Line Line PR Alarm source SpO2 SpO2 Alarm level Mid Mid Alarm record Off Off Alarm limits 50 120 on 75 160 on TEMP Alarm level Mid Mid Alarm record Off Off Display color White White Temperature unit T1 alarm limits 36 0 39 0 on 36 0 39 0 on T2 alarm limits 36 0 39 0 on 36 0 39 0 on TD alarm limits 0 0 2 0 on 0 0 2 0 on ...

Page 118: ... to do ST analysis 1 Check the ECG Setup ST Analysis ST Analysis is set to On 2 Check the ECG Setup Other Setup Paced whether be set to On If Paced is set to On means the patient have a pacemaker in this case the machine is not doing the ST analysis No SpO2 waveform or value Check whether the SPO2 Sensor is connected and in good condition Blood pressure does not start 1 Check whether the pump is b...

Page 119: ...l increase the electromagnetic emission and reduce the electromagnetic immunity of the device Do not put the device close to other devices or stack together When necessary observe the device closely to ensure that it runs normally in the environment The device requires special EMC protection and it is necessary to install and maintain it in the environment that meets the following EMC information ...

Page 120: ...ectronic equipment RF emissions CISPR 11 Class A The BT 770 is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warning This BT 770 is intended for use by healthcare professionals...

Page 121: ... of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 3 5 𝑝𝑝 80 MHz to 800 MHz d 3 5 𝑝𝑝 800 MHz to 2 5 GHz d 7 3 𝑝𝑝 0 01 0 35 0 35 0 23 0 1 1 11 1 11 0 74 1 3 5 3 5 2 34 10 11 07 11 07 7 38 100 35 35 23 24 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equatio...

Page 122: ...0 4 5 2006 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 2004 5 Uт 95 dip in Uт for 0 5 cycles 40 Uт 60 dip in Uт for 5 cycles 70 Uт 30 dip in Uт for 25 cycles 5 Uт 95 dip in Uт for 5 ...

Page 123: ... fixed RF transmitters as deter mined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption ...

Page 124: ...ed 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 Service Telephone and Fax Numbers Telephone 82 31 750 0340 Fax 82 31 750 0344 Bistos Co Ltd 7th FL A Bldg Woolim Lions Valley 5 cha 302 Galmachi ro Jungwon gu Seongnam si Gyeonggi do...

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