Bistos BT-740 User Manual

4 (3)
Bistos BT-740 User Manual

BT-740 Patient monitor

Operation Manual

Keep this manual for future reference

P/N : 740-ENG-OPM-EUR-R01

BT-740 Operation manual

1

 

 

Proprietary Material

Information and descriptions contained in this manual are the property of Bistos Co., Ltd. and may not be copied, reproduced, disseminated, or distributed without express written permission from Bistos Co., Ltd.

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.

The information contained herein is subjects to change without notice.

Prepared by:

Bistos Co., Ltd.

7th FL., A Bldg., Woolim Lions Valley 5-cha,

302, Galmachi-ro, Jungwon-gu, Seongnam-si,

Gyeonggi-do, Korea

Telephone: +82 31 750 0340

Fax: +82 31 750 0344

Revision R01

June, 2019

Printed in Korea

Copyright © Bistos Corporation 2018. All rights reserved.

 

 

 

P/N : 740-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2019.06

BT-740 Operation manual

2

 

 

Contents

0.Safety information ······················································································ 6

0.1General precautions, warnings and cautions ···························································· 8

0.2Shock hazards ············································································································· 11

0.3Battery warnings········································································································· 12

0.4General precautions on environment ······································································· 13

1.System basics ······························································································ 14

1.1Intended use ··············································································································· 14

1.2Operating principle ····································································································· 16

1.3System configurations ································································································ 16

1.4Product outlook ·········································································································· 18

1.5Description of monitor ······························································································· 19

1.6Understanding the display ························································································· 23

1.7Smart Hotkeys ············································································································ 24

1.8Essential performance ································································································ 24

2.Preparing for operation ··············································································· 25

2.1Installation ·················································································································· 25

2.2Connecting to power ·································································································· 27

3.Basic operations ·························································································· 28

3.1Turn on························································································································ 28

3.2Turn off ······················································································································· 29

3.3Basic operations ········································································································· 29

3.4Operation mode ········································································································· 31

3.5Measurement setup ··································································································· 32

3.6Freezing waves ··········································································································· 32

3.7Other common setup ································································································· 33

4.Patient information management ······························································· 36

4.1Patient setup menu ···································································································· 36

4.2Admitting a patient ···································································································· 37

4.3Patient information····································································································· 38

4.4Discharging a patient ·································································································· 39

4.5Clear alarms ················································································································ 39

4.6Clear trend ·················································································································· 39

4.7Clear NIBP trend ········································································································· 40

5.Display format ····························································································· 41

5.1Selecting user interface ······························································································ 41

5.2Display description ····································································································· 41

6.Alarm············································································································ 44

6.1Alarm types ················································································································· 44

6.2Alarm condition priorities ·························································································· 44

6.3Alarm mode ················································································································ 45

 

 

 

P/N : 740-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2019.06

BT-740 Operation manual

3

 

 

6.4Alarm states ················································································································ 47

6.5Alarm setup················································································································· 49

6.6Latch alarm ················································································································· 51

6.7Manual event ············································································································· 52

6.8Alarm record ·············································································································· 52

7.ECG ·············································································································· 53

7.1Overview ····················································································································· 53

7.2Safety information ····································································································· 53

7.3Monitoring steps ········································································································ 54

7.4ECG display ················································································································· 57

7.5ECG setup ··················································································································· 58

7.6Alarm setup ················································································································ 60

8.RESP ············································································································ 61

8.1Overview ····················································································································· 61

8.2Safety information ····································································································· 61

8.3Placing electrodes for respiration monitoring ··························································· 61

8.4Respiration display ····································································································· 62

8.5Respiration setup ······································································································· 63

8.6Alarm setup ················································································································ 64

9.PR ················································································································ 65

9.1Overview ····················································································································· 65

9.2Display ························································································································ 65

9.3Setting PR sound ········································································································· 65

9.4Alarm setup ················································································································ 65

10.SpO2 ··········································································································· 66

10.1Overview ··················································································································· 66

10.2Safety information ··································································································· 66

10.3Monitoring steps ······································································································ 67

10.4Display ······················································································································ 68

10.5Setting SpO2 ·············································································································· 69

10.6Measuring influencing factors ·················································································· 70

10.7Alarm setup ·············································································································· 70

10.8Technical description ······························································································· 71

11.NIBP ··········································································································· 72

11.1Overview ··················································································································· 72

11.2Safety information ··································································································· 73

11.3Measurement limits ································································································· 74

11.4Measurement procedure ························································································· 75

11.5NIBP display ·············································································································· 76

11.6Setting inflation pressure ························································································· 77

11.7NIBP reset ················································································································· 77

11.8Clean and disinfection method of NIBP cuff ···························································· 77

11.9Alarm setup ·············································································································· 78

12.TEMP ········································································································· 79

12.1Overview ··················································································································· 79

 

 

 

P/N : 740-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2019.06

BT-740 Operation manual

4

 

 

12.2Safety information ··································································································· 79

12.3Measurement steps ································································································· 79

12.4Measurement requirements ···················································································· 79

12.5Temperature display ································································································ 80

12.6Setting temperature unit ························································································· 80

12.7Alarm setup ·············································································································· 81

12.8Technical description ······························································································· 81

13.Review ······································································································ 82

13.1Reviewing trend chart······························································································· 82

13.2Reviewing trend table ······························································································ 83

13.3NIBP measurement review ······················································································ 84

14.Battery ······································································································· 85

14.1Overview ··················································································································· 85

14.2Battery usage guide ·································································································· 86

14.3Checking battery performance ················································································ 87

14.4Battery recycling ······································································································· 87

15.Caring and cleaning ···················································································· 88

15.1Overview ··················································································································· 88

15.2Cleaning ···················································································································· 88

15.3Disinfection ·············································································································· 89

16.Maintenance ······························································································ 90

16.1Checking ··················································································································· 90

16.2Viewing software version information ····································································· 91

16.3Maintenance plan ···································································································· 91

16.4ECG calibration ········································································································· 91

17.Accessories ································································································ 93

18.Specifications ····························································································· 94

18.1Safety specification ·································································································· 94

18.2Hardware specifications ··························································································· 95

18.3Functional specification ··························································································· 96

19.Alarm information ······················································································ 100

19.1Physiological alarm ··································································································· 100

19.2Technical alarm ········································································································ 102

20.Default parameter configuration ································································ 104

21.Common faults and maintenance ······························································· 106

22.Manufacturer’s declaration on EMC ··························································· 107

22.1Electromagnetic emissions ······················································································· 108

22.2Recommended separation distances between portable and mobile RF communications equipment and BT-740 ····································································································· 109

22.3Electromagnetic immunity ······················································································· 110

 

 

 

P/N : 740-ENG-OPM-EUR-R01

Bistos Co., Ltd.

2019.06

BT-740 Operation manual

5

 

 

Product Warranty ······························································································ 112

Figure 1-1: Front view ············································································································ 18 Figure 1-2: Side view ············································································································· 18 Figure 1-3: Rear view ············································································································· 19 Figure 1-4: Front view ············································································································ 19 Figure 1-5: Side view ············································································································· 21 Figure 1-6: Rear view ············································································································· 22 Figure 1-7: Standard display ·································································································· 23 Figure 3-1: “Settings” menu ·································································································· 31 Figure 4-1: “Patient” menu ··································································································· 37 Figure 4-2: “Quick Admit” menu ··························································································· 37 Figure 4-3: “Patient Info” menu ···························································································· 38 Figure 5-1: Standard display··································································································· 41 Figure 5-2: Big ECG format ····································································································· 42 Figure 5-3: Big font format ···································································································· 43 Figure 5-4: ECG 7-Lead full screen format ············································································· 43 Figure 7-1: 3-Lead placement method ·················································································· 56 Figure 7-2: 5-Lead placement method ·················································································· 56 Figure 7-3: ECG wave in standard display format ·································································· 58 Figure 7-4: ECG parameter in standard display format ························································· 58 Figure 7-5: “ECG Setup” menu ······························································································ 59 Figure 8-1: 5-lead respiration electrode placement ······························································ 62 Figure 8-2: Respiration wave ································································································· 62 Figure 8-3: Respiration parameter display ············································································ 63 Figure 8-4: “RESP setup” menu ····························································································· 63 Figure 9-1: PR parameter display ·························································································· 65 Figure 10-1: SpO2 parameter display ····················································································· 68 Figure 10-2: SpO2 wave ········································································································· 68 Figure 10-3: “SpO2 Setup” menu···························································································· 69 Figure 11-1: NIBP parameter display ····················································································· 76 Figure 12-1: TEMP parameter display ··················································································· 80 Figure 13-1: Trend chart ········································································································ 82 Figure 13-2: “Trend” table ····································································································· 83 Figure 13-3: NIBP measurement review ················································································ 84

 

 

 

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0 Safety information

Before using BT-740 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. When used in conjunction with the following words, the symbols indicate:

WARNING

Can lead to serious injury or death.

CAUTION

Can lead to minor injury or product/property damage

The following symbols are placed on product, label, packaging and this manual in order to stand for the information about:

IPX1

IPX2

Used to identify safety information.

Be well-known this information thoroughly before using BT-740.

Used to identify safety information.

Be well-known this information thoroughly before using BT-740

Indicates the protection level against the ingress of liquid. IPX1 is protection against some water drops falling vertically.

It correspond the device, patient monitor and accessory, temperature sensor

Indicates the protection level against the ingress of liquid.

IPX2 is protection from some water drops when the device is tilted up to and including 15°.

It correspond the accessories for SpO2 and ECG.

Refer to operation manual. Read manual before placing the device.

Indicates DC power supply.

Indicates the device is in the battery operation mode.

Indicates nurse call interface.

Indicates network interface.

 

 

 

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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.

Indicates 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 storage.

Indicates the humidity limitation for operation, transport and storage.

Indicates the range of atmospheric pressure to which the medical device can be safely exposed.

 

 

 

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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.

0.1 General precautions, warnings and cautions

Examine the patient monitor and any accessories periodically to ensure that the cables, adapter cords and instruments do not have visible evidence of damage that may affect patient safety or performance. The recommended inspection interval is once per week or less. Do not use the patient monitor if there is any visible sign of damage.

Only the DC power adapter supplied with the BT-740 is approved for use with the device.

Do not attempt to service the BT-740 patient monitor. Only qualified service personnel by Bistos Co. Ltd. should attempt any needed internal servicing.

Perform periodic safety testing to insure proper patient safety. This should include leakage current measurement and insulation testing. The recommended testing interval 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 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-740 patient monitor if it fails to pass the power on self-test procedure.

During the operation, do not disconnect any cable.

The BT-740 patient monitor is intended to be used by clinical professionals or trained doctors, nurses or laboratory assistant.

Do not service and maintain or clean the device including accessories while in use with a patient.

 

 

 

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Using the device to one patient at a time.

WARNING

Thoroughly read and understand the manual prior to use of the BT-740. Failure to do so could result in personal injury or equipment damage.

The device is intended for clinical patient monitoring, and only trained and qualified doctors and nurses should use the device.

The alarm volume, upper and lower alarm limits should be set according to the actual situation of the using environment. Do not just rely on audio alarm 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.

Use only the power adapter supplied with monitor.

Position the monitor where it is easy to de-energize the monitor when needed.

Do not open the enclosure to avoid an electric shock. Any repair and upgrade of monitor should be done by service personnel trained and authorized by Bistos. Co., Ltd.

When handling packaging materials, abide by local laws and regulations or hospital waste disposal regulations. Keep the packaging materials away from children.

Do not use in the presence of flammable anesthetics to prevent explosion or fire.

Install the power lines and cables of accessories carefully to avoid patient entanglement or suffocation, cables tangled or electrical interference.

When the monitor is used together with electrosurgical devices, the user (a doctor or a nurse) should ensure the safety of the patient and instrument.

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 tachometer alarm. Closely monitor the patients with pacemaker. For the inhibition of the device on pacemaker, refers to this manual.

Use of accessories other than those listed and approved for use with this product may result in increased emissions or decreased immunity.

Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information

 

 

 

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provided in this manual. In addition, portable and mobile RF communications equipment can affect medical electrical equipment.

The equipment shall not be used adjacent to other devices unless verification of normal operation in the configuration in which it is to be used can be achieved.

Keep matches, and all other sources of ignition, out of the room in which the patient monitor is located. Textiles, oils, and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen. Personal injury or equipment damage could occur.

A fire and explosion hazard exists when performing cleaning or maintenance procedures in an oxygen-enriched environment.

The patient monitor has been validated with the accessories and options listed in this manual and found to comply with all relevant safety and performance requirements applicable to the device. It is therefore the responsibility of 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 this manual.

Do not remove the covers of a BT-740 yourself to avoid damage to the equipment and unexpected electrical shock. Only qualified Bistos service engineer must repair or replace components.

CAUTION

Please install or carry the instrument properly to prevent damage due to falling, collision, strong vibration or other mechanical 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 damage or aging, replace the parts before use. The replacement should be made with same parts of original parts.

Before powering on the device, make sure that the power used by the device complies with the supply voltage and frequency requirements on the equipment label or in the Operator’s Manual.

 

 

 

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Equipment should be tested at least once a year, the test should be done and recorded by trained, have security testing knowledge and experienced personnel. If there are any problems in the tests, they must be repaired.

When the instrument and accessories are about to exceed the useful life (expected service life: 5 years), it must be treated in accordance with relevant local laws and regulations or the hospital's rules and regulations.

Do not connect to other equipment or network which not specified in the 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.

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, including neutral electrodes, do not come in contact with earth or any other conducting objects.

Protection of ME EQUIPMENT against effects of discharge of a cardiac defibrillator depends on use of proper cables.

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 permit a build-up of conductive 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

 

 

 

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Due to the risk of electrical shock hazard, only qualified personnel with appropriate service documentation should service the monitor.

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.

Do not open the battery compartment. Only the qualified service personnel authorized by the manufacturer can open the battery compartment and replace the battery, and batteries of same model and specification should be replaced.

Be careful when connecting 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 or burning.

When leakage or foul smell is found, stop using the battery immediately. If your skin or cloth comes into contact with leaked liquid, cleanse it with clean water at once. If the leaked liquid splashes into your eyes, do not wipe them. Irrigate them with clean water first and go to see a doctor immediately.

Properly dispose of or recycle the depleted battery according to local regulations.

 

 

 

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0.4 General precautions on environment

Do not keep or operate the equipment under the environment listed below.

 

Avoid placing in an area

 

Avoid exposure to direct

 

exposed to moisture. Do

 

 

not touch the equipment

 

sunlight

 

with wet hand.

 

 

 

 

 

 

 

Avoid placing in an area

 

 

 

where high variation of

 

 

 

temperature exists.

 

Avoid in the vicinity of

 

Operating temperature

 

 

 

electric heater.

 

ranges from 5 ~ 40 .

 

 

 

 

 

Operating humidity

 

 

 

ranges from 30% ~ 85 %.

 

 

 

 

 

 

 

Avoid placing in an area

 

Avoid placing in an area

 

where there is an

 

where there is an

 

excessive humidity rise

 

excessive shock or

 

or ventilation problem.

 

vibration.

 

 

 

 

 

Avoid placing in an area

 

Avoid dust and especially

 

where chemicals are

 

 

 

metal material enter into

 

stored or where there is

 

 

 

the equipment

 

in danger of gas leakage.

 

 

 

 

 

 

 

 

 

Do not disjoint or

 

Power off when the

 

 

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.

 

 

 

 

 

 

 

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1 System basics

1.1 Intended use

The BT-740 Patient Monitors acquire the physiological signals such as ECG, respiratory rate, non-invasive blood pressure (NIBP), Invasive Blood Pressure (IBP), blood oxygen saturation (SpO2), temperature. The signals are converted into digital data and processed, examines the data for alarm conditions and display the data. The monitor also provides operating control for the user. 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-740 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 (SpO2), noninvasive blood pressure (NIBP), temperature (TEMP), invasive blood pressure (IBP), CO2 and C.O. 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 (SpO2)

Indication:

-Monitoring effectives of oxygen therapy

-A reading is needed to facilitate the completion of an early warning score to inform

 

 

 

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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 ocardiovascular 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

 

 

 

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myocardial injury, ischemia and the presence of prior infarction, in the assessment of patients with electrolyte abnormalities, drug toxicities and implanted defibrillators and pacemakers.

-In addition to its usefulness in the evaluation of ischemic coronary disease, the ECG, in conjunction with ambulatory ECG monitoring, is of particular use in the diagnosis of disorders of the cardiac rhythm and in the evaluation of syncope. Other common uses of the ECG include the assessment of metabolic disorders and side effects of pharmacotherapy, 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. “Electrocardiography”,<Medscape>, Apr 17, 2017

Temperature (TEMP)

Indication:

-To obtain the baseline temperature to enable comparisons to be made with future 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 antimicrobial therapy for infection

-Using before and during a blood transfusion to monitor for signs of a reaction

Contraindications

-No known contraindications

1.2 Operating principle

Refer to the chapters for every physiological parameter from chapter 7 to chapter 12.

1.3 System configurations

Basic configuration of BT-740

Main body with 8” touch screen and built-in lithium-ion battery

ECG cable and electrode

Adult SpO2 probe and extension cable

Non-invasive blood pressure cuff

 

 

 

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Temperature probe

AC/DC adapter

Options of BT-740

External plug-in printer

 

Picture

Name

Description

Qty

 

 

ECG cable and

 

 

 

 

lead wire

Measures ECG

1ea

 

 

(standard)

 

 

 

 

 

 

 

 

 

ECG electrode

Electrode for ECG measurement

1ea

 

 

(standard)

 

 

 

 

 

 

 

 

 

 

 

Adult SpO2

 

 

 

 

sensor

SpO2 sensor for adult

1ea

 

 

(standard)

 

 

 

 

 

 

 

 

 

SpO2 extension

Cord to connect the SpO2 sensor and

1ea

 

 

cord

 

 

main body

 

 

(Standard)

 

 

 

 

 

 

 

 

 

 

 

 

Adult NIBP cuff

Measures NIBP for adult

1ea

 

 

(standard)

 

 

 

 

 

 

 

 

 

 

 

NIBP extension

Tube to connect the NIBP cuff and

1ea

 

 

tube

 

 

main body

 

 

(standard)

 

 

 

 

 

 

 

 

 

 

 

 

Temperature

 

 

 

 

sensor

Measures the body temperature

1ea

 

 

(Standard)

 

 

 

 

 

 

 

 

 

Adapter

For power supply

1ea

 

 

(Standard)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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1.4 Product outlook

Figure1-1: Front view

igure1-2 : Side view

 

 

 

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Figure1-3 : Rear view

1.5 Description of monitor

Figure1-4: Front view

 

 

 

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Name

 

Description

 

 

 

 

 

Indicates the priority of physiological alarm and technical

 

 

alarms in different colors and flashing frequencies.

1

Alarm indicator

-

High priority: Red, fast flashing (1.4 ~ 2.8 Hz)

 

 

-

Medium priority: Yellow, slow flashing (0.4 ~ 0.8 Hz)

 

 

- Low priority: Yellow, constant on

2

Display area

Display the waveform and measured value

 

 

 

 

 

- Power On: Press down the key more than 2 seconds.

3

 

- Power Off: Press down the keys more than 2 seconds

[Power]

 

and the system will display the alarm message “The

 

 

 

 

 

system will shut down 3 seconds”.

 

 

- On: The battery is being charged or has been fully

 

 

 

charged.

4

Battery indicator

- Off: The battery has not been installed.

 

 

- Flashing: The monitor is being powered by the

 

 

 

battery.

5

DC power indicator

Turned on when the monitor is being powered by the

adapter.

 

 

6

[Alarm reset]

To reset the alarm condition.

 

 

 

 

 

To pause the alarm sound. Alarm pause time can be set

7

[Alarm pause]

as 1 , 2, 3, 4, 5, 10, 15 minutes, and permanent. Default

 

setting is 2 minutes.

 

 

8

 

Start and stop the non-invasive blood pressure

[NIBP start/stop]

measurement.

 

 

 

 

9

Control knob

Rotate: move the cursor.

Press: select the menu or execute a command.

 

 

 

 

 

10

 

Enter to the setting mode. Press again to close the

[Setting]

setting mode.

 

11

[Freeze]

Freeze/unfreeze the waveform.

 

 

 

12

Speaker holes

For alarm and synchronizing sound

 

 

 

 

 

 

 

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Figure1-5: Side view

 

 

 

 

Name

Description

 

 

 

1

SpO2

SpO2 cable interface

 

 

 

2

T1

Temperature probe interface

 

 

 

3

T2

Temperature probe interface

 

 

 

4

ECG

ECG cable interface

 

 

 

5

NIBP

NIBP cuff interface

 

 

 

 

 

 

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Figure1-6: Rear view

 

Name

Description

 

 

 

1

Battery cover

Battery compartment cover

 

 

 

2

Handle

Handle for main body transport

 

 

 

3

Bracket

To wall mount the monitor

 

 

 

4

Air intake

For ventilation

 

 

 

5

Auxiliary output interface

Nurse call

 

 

 

6

Network port

For CMS

 

 

 

7

USB port

For software upgrade

 

 

 

8

Power adapter

15V, 2.4A adapter

 

 

 

 

 

 

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1.6 Understanding the display

 

Figure 1-7: Standard display

 

 

 

 

 

Name

 

Description

 

 

 

1

Information area

Include patient information, alarm status icon,

physiological and technical alarms.

 

 

 

 

Mainly display the waves of physiological

2

Waveform area

parameters with name of the parameter on the

 

 

left side.

 

 

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

3

Parameter area

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 brightness icon.

 

 

5

Hot key icons

Shows the hotkeys, which are frequently used for

some common operations.

 

 

6

Date and Time area

Display the current date and time.

 

 

 

 

 

 

 

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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.

Key

Name

Description

 

 

 

 

[Pause]

Alarm pause

 

 

 

 

[Pat. Set]

Patient information setting

 

 

 

 

[NIBP]

NIBP measurement start and stop

 

 

 

 

[Event]

Manual event mark

 

 

 

 

[Displays]

Change the display format

 

 

 

 

[Freeze]

Freeze the waveform

 

 

 

 

[Trend]

Trend display

 

 

 

 

[Print]

Print key

 

 

 

 

[Settings]

Setup menu

 

 

 

 

[Volume]

Volume setup key

 

 

 

 

[Unlock]

Touch screen lock key

 

 

 

1.8 Essential performance

The multi-function patient monitor BT-740 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, NIBP, etc. using ECG cable and specific probes and sensors. The detected analog signal amplifies and converted to digital. This concerted data feed to the CPU and converted to the display format as number and waveform. This device is incorporated with alarm system. The alarm generated when the detected signal range is beyond the user set alarm limits.

 

 

 

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2 Preparing for operations

2.1 Installation

To ensure normal working of the monitor, read this chapter before use, and install as required.

WARNING

All analog and digital devices connected to the monitor must be certified by IEC standards (e.g. IEC 60950 Data processing equipment standard and IEC 60601-1 Medical equipment standard). Furthermore, all configurations shall comply with valid version of IEC 60601-1 standard. The personnel connecting additional devices to the input / output signal ports are responsible for the compliance with IEC 60601-1 standard. If there is any question, please contact Bistos.

If the patient cable interface and network interface are connected with multiple devices, the total electric leakage current cannot exceed the allowable value.

The copyright of monitor software belongs to our company. Without permission, 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 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 must ensure that the following space, power, environmental requirements are met.

2.1.1 Unpack and check

BT-740 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. Check if there is any mechanical damage, the all listed are completely packed. If you have questions, please contact the marketing department of Bistos or agency.

Please keep the packing box and materials for use in future transporting or storage.

 

 

 

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2.1.2 Placement requirements

Equipment installation must meet:

-Ensure that the operating floor and the monitor have enough space for connecting the accessory wires.

2.1.3Power requirements

-DC power supply adapter

Input: A.C. 100 V ~ 240 V, 50/60 Hz Output: D.C. 15 V, 2.4 A

-Built-in rechargeable lithium-ion battery: D.C. 11.1 V, 4400 mAh

2.1.4 Environmental requirements

The storage, transport and use of the monitor must meet the following environmental requirements.

Operating

Ambient temperature

5 ~ 40

 

 

Relative humidity

30 % ~ 85 % (Non-condensing)

environment

Atmospheric pressure

700 ~ 1060 mbar (hPa)

 

Transportation

Prevent severe shock, vibration, rain and snow splashing during transport.

 

The packaged monitor should be stored in well-ventilated room with

Storage

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 explosive materials. In order to allow air flowing smoothly and achieve good heat dissipation, at least 2 inches (5cm) clearance should be kept around the device.

When the device is moved from one environment to another, the device may have condensation due to the differences in temperature or humidity. In this case, wait until the condensation disappears before using the device.

WARNING

Ensure that the monitor is used under specified environment. Fail to do this, the technical specifications declared in this manual may not be met and it may result in damage to equipment and other unforeseen consequences.

 

 

 

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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.100V240V, 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.

 

 

 

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3 Basic operations

3.1 Turn on

3.1.1 Check the monitor

-Before turn on the monitor, check whether there is mechanical damage to the monitor, and whether the external cables and accessories are connected correctly.

-Plug the power adapter into the AC power outlet. 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 damaged, or fails to work normally, do not use it for patient monitoring. Please contact the maintenance personnel or Bistos immediately.

3.1.2Start 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, 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.

-If the monitor equipped with a battery, charge the battery after each use to ensure sufficient power.

-After unpacking, when use the monitor first time, the monitor should be powered with adapter.

3.1.3 Connect the sensors

Connect the required sensor to the monitor and the monitoring site of patient.

 

 

 

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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.

-The operator can operate according to their own habits, standing in front, left or right of the monitor, easy to observe and operate the monitor.

3.2 Turn off

Turn off the monitor in the following steps

-Disconnect the cables and sensors connected to the patient.

-Press 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 operations:

-Rotate: Rotate control knob clockwise or counter clockwise to move the cursor.

-Press: Press control knob to perform an action, such as access to a menu or execute a command.

Control knob is the main control means. On the interface or the menu, the green highlighted box that moves with the knob turning is called the cursor. By turning the control knob, you can position the cursor in order to perform the desired operation.

 

 

 

P/N : 740-ENG-OPM-EUR-R01

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