Bistos BT-720 Operation Manual

BT-720 Patient monitor Operation Manual
Keep this manual for future reference
P/N : 720-ENG-OPM-EUR-R03
BT-720 Operation manual
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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.
th
7 302, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea
Telephone: +82 31 750 0340 Fax: +82 31 750 0344
Revision R03 October, 2020
Printed in Korea Copyright © Bistos Corporation 2018. All rights reserved.
P/N:720-ENG-OPM-ENG-R03 Bistos Co., Ltd. 2020.10
FL., A Bldg., Woolim Lions Valley 5-cha,
BT-720 Operation manual
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Contents

0. Safety information --------------------------------------------------------------------------4

0.1 General precautions, warnings and cautions --------------------------------------5

0.2 Shock hazards -----------------------------------------------------------------------------7

0.3 Battery warnings -------------------------------------------------------------------------8

0.4 General precautions on environment -----------------------------------------------9

1. System basics -------------------------------------------------------------------------------9

1.1 Intended use ------------------------------------------------------------------------------10

1.2 Operating principle ----------------------------------------------------------------------10

1. 3 System configurations ------------------------------------------------------------------10

1. 4 Product outlook --------------------------------------------------------------------------1 1

1. 5 Description of monitor -----------------------------------------------------------------1 1

1. 6 Understanding the display ------------------------------------------------------------12

1.7 Essential performance ------------------------------------------------------------------13

2. Preparing for operation ------------------------------------------------------------------13

2.1 Installation --------------------------------------------------------------------------------13

2.2 Connecting to power -------------------------------------------------------------------14

3. Basic operations ---------------------------------------------------------------------------14

3.1 Turn on -------------------------------------------------------------------------------------14

3.2 Turn off ------------------------------------------------------------------------------------15

4. Setup the monitor -------------------------------------------------------------------------1 5

5. SpO

6. NIBP -------------------------------------------------------------------------------------------19

7. Review ----------------------------------------------------------------------------------------24

8. Alarm ------------------------------------------------------------------------------------------25

9. Battery ----------------------------------------------------------------------------------------26

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5.1 Overview -----------------------------------------------------------------------------------17

5.2 Safety information ----------------------------------------------------------------------17

5.3 Monitoring steps -------------------------------------------------------------------------18

5.4 Setting SpO
2 -------------------------------------------------------------------------------------------------------------------------
18

5.5 Measuring influencing factor ---------------------------------------------------------19

5.6 Technical description -------------------------------------------------------------------19

6.1 Overview ----------------------------------------------------------------------------------19

6.2 Safety information ----------------------------------------------------------------------20

6.3 Measurement limits --------------------------------------------------------------------21

6.4 Measurement procedure --------------------------------------------------------------21

6.5 Setting NIBP -------------------------------------------------------------------------------22

6.6 Clean and disinfection method of NIBP cuff --------------------------------------2 3

9.1 Overview -----------------------------------------------------------------------------------26

9.2 Battery usage guide ---------------------------------------------------------------------26

9.3 Checking battery performance -------------------------------------------------------27

9.4 Battery recycling -------------------------------------------------------------------------27

BT-720 Operation manual
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10. Caring and cleaning -----------------------------------------------------------------------27

10 .1 Overview ---------------------------------------------------------------------------------27 10 .2 Cleaning ----------------------------------------------------------------------------------27 10 .3 Disinfection ------------------------------------------------------------------------------28

11. Maintenance --------------------------------------------------------------------------------28

11.1 Checking ----------------------------------------------------------------------------------28

11.2 Maintenance plan ----------------------------------------------------------------------29

12. Accessories --------------------------------------------------------------------------------- 29

13. Specifications -------------------------------------------------------------------------------30

13.1 Safety specification --------------------------------------------------------------------30

13.2 Hardware specifications --------------------------------------------------------------30

13.3 Functional specification --------------------------------------------------------------31

14. Common faults and maintenance -----------------------------------------------------32

15. Manufacturer’s declaration on EMC -------------------------------------------------33

15.1 Electromagnetic emissions ----------------------------------------------------------33

15.2 Recommended separation distances between portable and mobile RF communications equipment and BT- 720 -----------------------------------------------3 4

15.3 Electromagnetic immunity ----------------------------------------------------------35

Product Warranty --------------------------------------------------------------------------------37

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BT-720 Operation manual
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WARNING
CAUTION
Used to identify safety information. Be well-known this information thoroughly before using BT-720.
Used to identify safety information.
Indicates the protection level against the ingress of liquid.
It correspond the device, patient monitor.
Indicates the protection level against the ingress of liquid.
It correspond the accessories for SpO2.
Indicates DC power supply.
Indicates the device is in the battery operation mode.
0 Safety information
Before using BT-720 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:
Can lead to serious injury or death.
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:
Be well-known this information thoroughly before using BT-720
IPX1
IPX2
IPX1 is protection against some water drops falling vertically.
IPX2 is protection from some water drops when the device is tilted up to and including 15°.
Refer to operation manual. Read manual before placing the device.
Indicates nurse call interface.
Indicates network interface.
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)
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Indicates the date after which the medical device is not to be used.
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Indicates to not dispose the device together with unsorted municipal
put on the market after 13 August 2005.
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.
Indicates the device contains natural rubber latex.(Accessories)
Indicates the packing material is recyclable.
waste(for EU only). The solid bar symbol indicates that mains adapter is
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-720 is approved for use with the device.
Do not attempt to service the BT-720 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-720 patient monitor if it fails to pass the power on self-test
procedure.
During the operation, do not disconnect any cable.
The BT-720 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.
Using the device to one patient at a time.
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WARNING
An operator may only perform maintenance procedures specifically described in
Thoroughly read and understand the manual prior to use of the BT-720. 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 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.
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this manual.
or replace components.
CAUTION
Please install or carry the instrument properly to prevent damage due to falling,
depends on use of proper cables.
WARNING
Unplug the monitor from its power source prior to cleaning or maintenance to prevent
a build-up of conductive dust or dirt. Do not allow cleaning agents to contact electrical
Do not remove the covers of a BT-720 yourself to avoid damage to the equipment
and unexpected electrical shock. Only qualified Bistos service engineer must repair
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.
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
0.2 Shock hazards
personal injury or equipment damage.
Some chemical cleaning agents may be conductive and leave a residue that may permit
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components and do not spray cleaning solutions onto any of these surfaces. Personal
service documentation should service the monitor.
WARNING
Improper operation may cause the internal lithium ion battery to be hot, ignited or
Properly dispose of or recycle the depleted battery according to local regulations.
Avoid placing in an area where
30 % ~ 85 %.
Power off when the
could be damaged.
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 the risk of electrical shock hazard, only qualified personnel with appropriate
0.3 Battery warnings
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.
0.4 General precautions on environment Do not keep or operate the equipment under the environment listed below.
Avoid placing in an area exposed to moisture. Do not touch the equipment with wet hand.
Avoid exposure to direct sunlight
high variation of temperature exists. Operating temperature ranges from 5 Operating humidity ranges from
~ 40.
Avoid placing in an area where there is an excessive humidity rise or ventilation problem.
Avoid placing in an area where chemicals are stored or where there is in danger of gas leakage.
Do not disjoint or disassemble the device. Bistos Co., Ltd. does not have liability of it.
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Avoid in the vicinity of electric heater.
Avoid placing in an area where there is an excessive shock or vibration.
Avoid dust and especially metal material enter into the equipment
equipment is not fully ready to operate. Otherwise, the equipment
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Blood oxygen saturation (SpO2)
Indication:
in pulmonary
rehabilitation
Contraindications
be hypoxic
Source: NHS. “Clinical Procedure_ Procedure for Pulse Oximetry/SPO2”. Wirral Community NHS Trust. Sep, 2013
Non-invasive blood pressure (NIBP)
Indication:
- Assessing a person’s suitability for a spot or certain occupations
1 System basics
1.1 Intended use The BT-720 Patient Monitors acquire the physiological signals for non-invasive blood pressure (NIBP), pulse rate (PR) and blood oxygen saturation (SpO 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, operating room, emergency department, to provide additional information to the medical and nursing staff about the physiological condition of the patient. Th e BT-720 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 blood oxygen saturation (SpO
), pulse rate (PR) and monitoring. It is equipped with a replaceable built-in battery to
2
provide convenience for the patient movement in hospital.
5) Indications and contraindications
- 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.
). The signals are converted into digital data and
2
- 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
- To determine a patient’s blood pressure
- Screen for hypertension
- Following the effect of anti-hypertensive treatments in a patient to optimize their
management
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- Estimation of cardiovascular risk
- Figuring out whether a patient is clinically deteriorating or is at risk.
Contraindications
removal post mastectomy.
Source: [1] NHS. “Clinical Procedure_ Procedure for Blood Pressure Monitoring”. Wirral
. Queensland Government, 2016.
https://www.ambulance.qld.gov.au/clinical.html
Picture
Name
Description
Qty
- Determining for the risk of various medical procedure
- 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
Community NHS Trust. Dec, 2013
[2] Clinical Quality& Patient Safety Unit, QAS. Clinical Practice Procedures:
Assessment/Non-invasive blood pressure
1.2 Operating principle
Refer to the chapters for every physiological parameter from chapter 5 to chapter 6.
1.3 System configurations
Basic configuration of BT-720
Main body with 4.3” touch screen and built-in lithium-ion battery
Adult SpO2 probe and extension cable
AC/DC adapter
Options of BT-720
Non-invasive blood pressure cuff
Adult SpO2 sensor
(standard)
SpO2 extension cord
(Standard)
Adult NIBP cuff
(Option)
NIBP extension tube
(Option)
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Adapter
(Standard)
SpO2 sensor for adult 1ea
Cord to connect the SpO2 sensor and main body
Measures NIBP for adult 1ea
Tube to connect the NIBP cuff and main body
For power supply 1ea
1ea
1ea
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Name
Description
NIBP tube interface. This is option. When you purchase the monitor only with SpO2, this interface will be blocked.
2
SpO2
SpO2 cable interface
3
Display area
Display the waveform and measured value
Indicates the priority of physiological alarm and technical alarms in
- Low priority: Yellow, constant on
[Setting]
[NIBP]
invasive blood pressure measurement manually.
[Alarm reset]
1.4 Product outlook
Figure1-1: Front view
1.5 Description of monitor
1 NIBP
4 Alarm indicator
5
different colors and flashing frequencies.
- High priority: Red, fast flashing (1.4 ~ 2.8 Hz)
- Medium priority: Yellow, slow flashing (0.4 ~ 0.8 Hz)
Enter to the setting mode. Press again to close the setting mode.
Figure1-3: Front view
Figure1-2 : Rear view
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7
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Start and stop the non­This is option. When you purchase only with SpO2 this button will be deleted.
To reset the alarm condition.
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