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BT-780 Operation manual

 

 

P/N : 780-ENG-OPM-EXP-R00 

Bistos Co., Ltd. 

2020.03 

1 System basics

1.1 Intended use 

The BT-780 Patient Monitors  acquire the physiological signals such as ECG, respiratory rate, non-invasive blood pressure (NIBP), 

blood oxygen saturation (SpO

2

) and temperature. The signals are converted into digital data and processed, examines the data for 

alarm conditions and display them. The patient monitor intend to use in hospital clinical area such as intensive care units, cardiac 

care units, operating room, emergency department, to provide additional information to the medical and nursing staff about the 

physiological condition of the patient.  The BT-780 patient  monitors are intended to be used only under regular supervision of 

clinical personnel. It is suitable for adult and pediatric, neonate. The intended locations of use are hospitals and clinics. 

1) Intended patient population 

-

 

Adult (>18 years adults) and Pediatrics (30 days < and <18 years) and Neonate (0 days

 and 

30days) 

2) Intended user profile 

-

 

Doctor, physicians or nursing staff who is qualified personnel  

-

 

Basic experiences or knowledge on medical field, especially on patient monitoring 

-

 

Trained or requested to read IFU before use   

3) Environment of use 

-

 

Hospital and clinic 

-

 

Requirements: Stable power source 

4) Scope of application 

This monitor is suitable for bedside monitoring of patient.   This monitor enables ECG, respiration (RESP), pulse rate (PR), blood 

oxygen saturation (SpO

2

), noninvasive blood pressure (NIBP) and temperature (TEMP) monitoring. It is equipped with a replaceable 

built-in battery to provide convenience for the patient movement in hospital. 

5) Indications and contraindications 

Blood oxygen saturation (SpO

2

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. cardiac failure or Myocardial Infarction) 

Respiratory illness e.g. asthma, chronic obstructive pulmonary disease 

Monitoring during administration of respiratory depressant drugs, e.g. opiate epidural or patient-

controlled analgesia. 

Assessing oxygen saturation during physical activity e.g. in pulmonary rehabilitation 

Contraindications 

Pulse oximetry does not give an indication of haemoglobin so if the patient is profoundly anaemic then 

their oxygen saturation may by normal but they may still be hypoxic 

Source: NHS. “

Clinical Procedure_ Procedure for Pulse Oximetry/SPO2

”. Wirral Community NHS Trust. Sep, 2013 

Non-invasive blood 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 or is at risk. 

Contraindications 

Oscillometric blood pressure devices may not be accurate in patients with weak or thready pulse  

In patients with heart beats below 50 beats/minutes, even if the rhythm is regular, some of the semi-

automatic devices are unable to reduce their deflation rate sufficiently so that too rapid a falling in cuff 

pressure results in underestimation of systolic blood pressure and overestimation of diastolic blood 

pressure. 

Do not apply to limb with AV fistula, significant injury or burn, or lymph node removal post mastectomy. 

Source: [1] NHS. “

Clinical Procedure_ Procedure for Blood Pressure Monitoring

”. Wirral Community NHS Trust. Dec, 

2013 

 [2] Clinical Quality& Patient Safety Unit, QAS. 

Clinical Practice Procedures: Assessment/Non-invasive blood 

pressure

. Queensland Government, 2016. https://www.ambulance.qld.gov.au/clinical.html 

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. 

Summary of Contents for BT-780

Page 1: ...BT 780 Patient monitor Operation Manual Keep this manual for future reference P N 780 ENG OPM EXP R00...

Page 2: ...r 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 und...

Page 3: ...ng waves 16 3 7 Other common setup 16 4 Patient information management 17 4 1 Patient setup menu 17 4 2 Admitting a patient 17 4 3 Patient information 18 4 4 Discharging a patient 18 4 5 Clear alarms...

Page 4: ...Review 35 13 1 Reviewing trend chart 36 13 2 Reviewing trend table 36 13 3 NIBP measurement review 36 14 Battery 37 14 1 Overview 37 14 2 Battery usage guide 37 14 3 Checking battery performance 37 14...

Page 5: ...nown this information thoroughly before using BT 780 IPX1 Indicates the protection level against the ingress of liquid IPX1 is protection against some water drops falling vertically It correspond the...

Page 6: ...val is once per year If the hospital or healthcare institutions using this device fail to implement a satisfactory maintenance schedule it will result in device failure and may endanger the patient s...

Page 7: ...f the person or organization who makes an unauthorized modification or incorporates an unapproved attachment to the device An operator may only perform maintenance procedures specifically described in...

Page 8: ...mental 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 h...

Page 9: ...tory illness e g asthma chronic obstructive pulmonary disease Monitoring during administration of respiratory depressant drugs e g opiate epidural or patient controlled analgesia Assessing oxygen satu...

Page 10: ...ture recordings To enable close observation in resolving hypothermia hyperthermia To observe and monitor patients for changes indicating an infection To monitor the effect of treatment for antimicrobi...

Page 11: ...e1 2 Side view Figure1 3 Rear view 1 5 Description of monitor Figure1 4 Front view Name Description 1 Alarm indicator Indicates the priority of physiological alarm and technical alarms in different co...

Page 12: ...Rear view Name Description 1 Air outlet Heat dissipation 2 Handle Handle for main body transport 3 Speaker holes For alarm and synchronizing sound 4 ID label Identify the monitor information 5 USB po...

Page 13: ...f 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 ba...

Page 14: ...n any 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...

Page 15: ...let If using battery power make sure the battery is fully charged Check all the functions required for patient monitoring to make sure that the monitor operates properly WARNING If the monitor is dama...

Page 16: ...enus is basically similar to the Settings mode as shown below You can set up the monitor screen if you need Menu title A title of the current menu Close menu Close the current menu Exit the current me...

Page 17: ...e screen Select Department Enter the sector and department using the device through the soft keyboard on the screen Select Bed Number Enter the bed number through the soft keyboard on the screen 3 7 2...

Page 18: ...y is very important If the monitor has admitted the patient it is recommended to operate the monitor to discharge the current patient before connecting to not admitted the next patient Otherwise the d...

Page 19: ...onate 7 Select Pace Maker and set whether the patient wears a pacemaker 8 Select Height cm and set the patient s height via the pop up keyboard on the screen Range 0 250 9 Select Weight kg and set the...

Page 20: ...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 displ...

Page 21: ...s the alarm limit or the patient has physiological abnormalities The information of physiological alarm is displayed in the physiological alarm area on top of the screen Technical alarms Technical ala...

Page 22: ...ority 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 inf...

Page 23: ...utes 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 and the monitor will turn off the alarm In this case except the alarm prompt characteris...

Page 24: ...tive range of the system and the upper alarm limit must be higher than the lower alarm limit Select SpO2 Low Limit and set the lower limit of SpO2 alarm Select SpO2 High Limit and set the upper limit...

Page 25: ...for defibrillation proof so the monitor operates normally after defibrillation NOTE In the factory setup ECG wave display in the first two waves from top in the wave area in the normal display format...

Page 26: ...isual alarm 7 3 2 Selecting lead Select the ECG parameter area or wave area ECG Setup menu Select Other Setup ECG Other Setup menu Select Lead Type and select the ECG lead as needed 3 Lead 3 lead ECG...

Page 27: ...art 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 p...

Page 28: ...be set Auto 0 25 0 5 1 2 4 Select Wave Speed and set the wave speed The wave speed is 12 5mm s 25mm s 50mm s The default is 25mm s Select Filter and set the filter mode Diagnostic Diagnostic mode Mon...

Page 29: ...ion electrode placement 8 3 1 Adjusting position of respiration electrode If you want to measure ECG and respiration simultaneously you may need to adjust the position of the two electrodes for respir...

Page 30: ...ty 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 alarm...

Page 31: ...will have deviation When the patient has a tendency to hypoxia use the oximeter to analyze blood samples in order to fully grasp the patient s condition Do not put the sensor on limbs with arterial du...

Page 32: ...ncy radio wave interference such as interference generated by the host system or interference from electrosurgery instrument connected to the system Intravenous dye Too frequent movement of the patien...

Page 33: ...fter complete a measurement start the next measurement continue 5 minutes then stop During measurement any error will stop the continuous measurement If the first measurement time is over 4 minutes an...

Page 34: ...beats min the blood pressure measurement is impossible Obese patients A thick layer of fat around a limb blocks the arterial oscillation so that it cannot reach the cuff The accuracy is lower than no...

Page 35: ...tient is neonate the pressure can be select from 100 120 The default cuff pressure value is 100 11 7 NIBP reset Select NIBP parameter area NIBP Setup menu Select Reset and restore the inflation pressu...

Page 36: ...mperature in the specified environment temperature range or else it may be dangerous 12 5 Temperature display The monitor can display the body temperature of two channels T1 and T2 and the alarm limit...

Page 37: ...r values of the time which will change automatically with the move of trend cursor 13 2 Reviewing trend table Select Trend smart hotkey to enter Trend menu select Tabular and enter the following windo...

Page 38: ...ry 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 compart...

Page 39: ...manufacturer s instructions Do not use abrasive materials such as steel wool Do not allow any liquid entering into the enclosure and never immerse any part of the device into liquid Do not leave any c...

Page 40: ...ue is not accurate NIBP leakage test At least once every two years or follow hospital regulations NIBP calibration At least once every two years or follow hospital regulations 16 4 ECG calibration In...

Page 41: ...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 Cate...

Page 42: ...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...

Page 43: ...Resolution 0 1 Measurement accuracy 0 3 Number of channel 2 Alarm T1 T2 upper limit 0 1 50 0 0 1 step T1 T2 lower limit 0 49 9 0 1 step TD upper limit 0 50 0 0 1 step RESP Measurement method Thoracic...

Page 44: ...ring 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...

Page 45: ...orks abnormally check the pacemaker Pacemaker Not work H ECG Signal weak H The patient ECG signal is too weak and the system can t analyze Check the patient s condition electrodes cables and leads ST...

Page 46: ...s 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 Sens...

Page 47: ...settings On On On On Mid Mid Mid Mid Off Off Off Off Gain x1 x1 x1 Wave velocity 25 0mm s 25 0mm s 25 0mm s Filter mode Monitor Monitor Monitor Wave color Green Green Green Wave style Color scale Col...

Page 48: ...whether the pressure sensor is normal If the above doesn t solve the problem please contact Bistos after sales department or dealers 22 Manufacturer s declaration on EMC BT 780 needs special precauti...

Page 49: ...and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection...

Page 50: ...is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transm...

Page 51: ...g BT 780 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...

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