Bistos BT-710 User Manual
BT-710 Hand held pulse oximeter
Operation Manual
Keep this manual for future reference
P/N : 710-ENG-OPM-EUR-R01
BT-710 Operation manual
1
P/N : 710-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2019.06
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
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.
Proprietary Material
BT-710 Operation manual
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P/N : 710-ENG-OPM-EUR-R01
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2019.06
Contents
0. Safety information ······················································································· 4
0.1 General precautions, warnings and cautions ···························································· 5
0.2 Shock hazards ············································································································· 8
0.3 Battery warnings········································································································· 9
0.4 General precautions on environment ······································································· 10
1. System basics ······························································································· 11
1.1 Intended use ··············································································································· 11
1.2 Operating principle ····································································································· 12
1.3 System configurations ································································································ 12
1.4 Product outlook ·········································································································· 12
1.5 Description of pulse oximeter ···················································································· 14
1.6 Understanding the display ························································································· 16
1.7 Essential performance ································································································ 17
2. Preparing for operation ················································································ 18
2.1 Installation ·················································································································· 18
2.2 Connecting to power ·································································································· 19
3. Basic operations ··························································································· 20
3.1 Turn on ························································································································ 20
3.2 Turn off ······················································································································· 21
4. Setup the pulse oximeter ············································································· 22
5. SpO
············································································································ 25
2
5.1 Overview ····················································································································· 25
5.2 Safety information ····································································································· 25
5.3 Monitoring steps ········································································································ 26
5.4 Setting SpO
5.5 Measuring influencing factors ···················································································· 29
5.6 Technical Description ································································································ 29
················································································································ 27
2
6. Review ········································································································ 31
7. Alarm ·········································································································· 33
7.1 Alarm types ··············································································································· 33
7.2 Alarm condition priorities ························································································· 33
7.3 Alarm mode ·············································································································· 34
7.4 Alarm state ················································································································ 35
7.5 Alarm information ····································································································· 36
8. Battery ········································································································ 38
8.1 Overview ····················································································································· 38
8.2 Battery usage guide····································································································· 38
8.3 Checking battery performance ·················································································· 39
8.4 Battery recycling ········································································································· 40
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9. Caring and cleaning ······················································································ 41
9.1 Overview ····················································································································· 41
9.2 Cleaning ······················································································································ 41
9.3 Disinfection ················································································································ 42
10. Maintenance ································································································ 43
10.1 Checking ··················································································································· 43
10.2 Trouble shootings ····································································································· 44
10.3 Maintenance plan ···································································································· 44
11. Accessories ·································································································· 45
12. Specifications ······························································································· 46
12.1 Safety specification ·································································································· 46
12.2 Hardware specifications ··························································································· 46
12.3 Functional specification ··························································································· 47
13. Manufacturer’s declaration on EMC ····························································· 48
13.1 Electromagnetic emissions ······················································································· 49
13.2 Recommended separation distances between portable and mobile RF communications
equipment and BT-710 ····································································································· 50
13.3 Electromagnetic immunity ······················································································· 51
Product Warranty ······························································································ 38
Figure 1-1: Front view ············································································································ 12
Figure 1-2: Rear view ············································································································· 13
Figure 1-3: Top view ·············································································································· 13
Figure 1-4: Bottom view ········································································································ 13
Figure 1-5: Front view ············································································································ 14
Figure 1-6: Top view ·············································································································· 15
Figure 1-7: Bottom view ········································································································· 15
Figure 1-8: Standard display ·································································································· 16
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WARNING
CAUTION
Indicates the protection level against the ingress of liquid.
It correspond the device and the accessory for SpO2.
manufacturer.
0 Safety informatio
Before using BT-710 Pulse oximeter, 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 pulse oximeter. 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:
IPX2
Used to identify safety information.
Be well-known this information thoroughly before using BT-710.
Used to identify safety information.
Be well-known this information thoroughly before using BT-710
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 the production date.
Indicates the manufacturer.
Indicates the serial number of the device.
Indicates the authorized representative in the European Community of
Indicates a BF applied part.
Indicates CLASS II equipment.(Adapter)
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Indicates the medical device that can be broken or damaged if not
on for operation, transport and
Indicates the date after which the medical device is not to be used.
Indicates to keep the device dry.
handled carefully.
Indicates to keep upright
Indicates the temperature limitati
storage.
Indicates the humidity limitation for operation, transport and storage.
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 pulse oximeter and any accessories periodically to ensure that the cables
including 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 pulse oximeter if there is any visible sign of
damage.
• Only the DC power adapter supplied with the BT-710 is approved for use with the
device.
• Do not attempt to service the BT-710 pulse oximeter. Only qualified service personnel
by Bistos Co. Ltd. should attempt any needed internal servicing. There is no user
serviceable part.
• 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 pulse oximeter under the conditions specified in this operation manual.
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WARNING
• Thoroughly read and understand the manual prior to use of the BT-710. Failure
regulations or hospital waste disposal regulations. Keep the away from
to prevent explosion or
cables of accessories carefully to avoid patient
• The physiological wave, physiological parameters and alarm information
Beyond the conditions, the pulse oximeter may not function properly and the
measurement results may not accurate and may result in device failure or
endangering the patient’s safety.
• During the operation, do not disconnect any cable.
• Do not operate the BT-710 pulse oximeter if it fails to pass the power on self-test
procedure.
• The BT-710 pulse oximeter 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.
to do so could result in personal injury or equipment damage.
• The device is intended for measure the clinical blood oxygen saturation via
pulse oximeter, 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 pulse oximeter.
• Do not open the enclosure to avoid an electric shock. Any repair and upgrade
of pulse oximeter should be done by service personnel trained and authorized
by Bistos. Co., Ltd.
• When handling packaging materials and the device, abide by local laws and
children.
• Do not use in the presence of flammable anesthetics
fire.
• Install the power lines and
entanglement or suffocation, cables tangled or electrical interference.
• When the pulse oximeter is used together with electrosurgical devices, the user
(a doctor or a nurse) should ensure the safety of the patient and instrument.
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displayed on the pulse oximeter are only for the doctor’s reference and should
Medical electrical equipment needs special precautions regarding EMC and
The equipment shall not be used adjacent to other devices unless verification
Keep matches, and all other sources of ignition, out of the room in which the
is located. Textiles, oils, and other combustibles are easily
n this
manual and found to comply with all relevant safety and performance
person or organization who makes an unauthorized modification, or
yourself to avoid damage to the
equipment and unexpected electrical shock. Only qualified Bistos service
engineer must repair or replace components.
CAUTION
Avoid using pulse oximeter in the environment such as pressure is too high,
not be directly used as the basis for clinical treatment.
• This is not a therapeutic device.
• Use of accessories other than approved for use with this product may result in
increased emissions or decreased immunity.
•
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.
•
of normal operation in the configuration in which it is to be used can be
achieved.
•
pulse oximeter
ignited and burn with great intensity in oxygen rich environment. Personal
injury or equipment damage could occur.
• A fire and explosion hazard exists when performing cleaning or maintenance
procedures in an oxygen rich environment.
• The pulse oximeter has been validated with the accessories listed i
requirements applicable to the device. It is therefore the responsibility of the
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-710
• Please install or carry the pulse oximeter properly to prevent damage due to
falling, collision, strong vibration or other mechanical force.
• Avoid instrument splashed by water.
range of 5 ℃ ~ 40 ℃。
• Avoid high temperatures, the instrument should be used within a temperature
•
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poor ventilation, dusty, or contain salt, sulfur gas and chemical.
Before powering on the device, make sure that the power used by the device
oltage and frequency requirements on the
Equipment should be tested at least once a year, the test should be done and
testing knowledge and experienced
When the instrument and accessories are about to exceed the useful life
Do not connect any equipment or accessories that are not approved by the
operation and safety are not
Parts and accessories used must meet the requirements of the applicable
safety standards, and/or the system configuration must meet the
Ensure that the conductive parts of electrodes and associated connectors,
including neutral electrodes, do not come in contact with earth or any other
WARNING
Unplug the pulse oximeter from its power source prior to cleaning or maintenance
ome 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
• Before using the pulse oximeter, check the pulse oximeter 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.
•
complies with the supply v
equipment label or in this manual.
•
recorded by trained, have safety
personnel. If there are any problems in the tests, they must be repaired.
•
(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.
•
manufacturer or according to IEC 60601-1 to the pulse oximeter. The operation
or use of non-approved equipment or accessories with the pulse oximeter is
not tested or supported, and pulse oximeter
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.).
•
requirements of the medical electrical systems standard.
•
conducting objects.
0.2 Shock hazards
to prevent personal injury or equipment damage.
S
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contact electrical components and do not spray cleaning solutions onto any of
WARNING
Improper operation may cause the internal lithium ion battery to be hot, ignited or
nly the qualified service personnel
Do not destroy the battery. Do not pierce battery with a sharp object such as a
disassemble or modify the battery. The battery can heat, smoke, deformation or
Properly dispose of or recycle the depleted battery according to local regulations.
these surfaces. Personal injury or equipment damage could occur.
Do not expose the pulse oximeter 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
service documentation should service the pulse oximeter.
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. O
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.
needle. Do not hit with a hammer, step on or throw or drop the battery. Do not
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.
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Avoid placing in an area
Power off when the pulse
0.4 General precautions on environment
Do not keep or operate the pulse oximeter under the environment listed below.
Avoid placing in an area
exposed to moisture. Do
not touch the pulse
oximeter with wet hand.
where high variation of
temperature exists.
Operating temperature
ranges from 5
Operating humidity
℃ ~ 40℃.
ranges from 30 % ~ 85 %.
Avoid exposure to direct
sunlight
Avoid in the vicinity of
electric heater.
Avoid placing in an area
where there is an
excessive humidity rise
or ventilation problem.
Avoid placing in an area
where chemicals are
stored or where there is
in danger of gas leakage.
Do not disjoint or
disassemble the pulse
oximeter. Bistos Co., Ltd.
does not have liability of
it.
Avoid placing in an area
where there is an
excessive shock or
vibration.
Avoid dust and especially
metal material enters
into the pulse oximeter.
oximeter is not fully
ready to operate.
Otherwise, the pulse
oximeter could be
damaged.
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1 System basics
1.1 Intended use
The BT-710 pulse oximeters acquire the blood oxygen saturation (SpO2) and pulse rate (PR).
The signals are converted into digital data and processed, examines the data for alarm
conditions and display the data. The pulse oximeter also provides operating control for the
user. The pulse oximeter intend to use in hospital clinical area such as general ward, to provide
additional information to the medical and nursing staff about the blood oxygen saturation of
the patient. The BT-710 pulse oximeters 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 pulse oximeter is suitable for bedside monitoring of patient. This pulse oximeter enables
the monitoring of blood oxygen saturation (SpO
) and pulse rate (PR). It is equipped with a
2
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
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- 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
1.2 Operating principle
Refer to the chapters for every physiological parameter from chapter 5.
1.3 System configurations
Basic configuration of BT-710
• Main body with 4.3” touch screen and built-in lithium-ion battery
• Adult SpO
• AC/DC adapter
sensor probe
2
1.4 Product outlook
Figure1-1: Front view
BT-710 Operation manual
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2019.06
Figure1-2 : Rear view
Figure1-3 : Top view
Figure1-4 : Bottom view
BT-710 Operation manual
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P/N : 710-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2019.06
Turned on when the pulse oximeter is being powered by
- Power On: Press down the key more than 2 seconds.
s
The
system will shut down 3 seconds”.
[Alarm reset]
[Setting]
Enter to the setting mode. Press again to close the setting
1.5 Description of pulse oximeter
1
2
3
Name Description
DC power indicator
Display area Display the waveform and measured value
[Power]
4
5
Figure1-5: Front view
the adapter.
- Power Off: Press down the keys more than 2 second
and the system will display the alarm message “
To reset the alarm condition.
mode.
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2019.06
Figure1-6: Top view
6
Name Description
SpO2 SpO2 sensor probe interface
Figure1-7: Bottom view
7
8
9
Name Description
SD card interface For software upgrade
Power adapter 5V, 2A adapter
Lanyard eyelet
For convenient hand held
BT-710 Operation manual
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P/N : 710-ENG-OPM-EUR-R01
Bistos Co., Ltd.
2019.06
Current alarm message. When an alarm occurs, this area will displayed yellow
or red depending on the alarm type.
SpO2 waveform. Display the measured SpO2 waveform. The waveform is not
Sleep mode. Touch this area makes the pulse oximeter to enter the sleep
1.6 Understanding the display
Figure 1-8: Standard display
Description
1
2 SpO2 value. Display the measured SpO2 value.
3 SpO2 upper alarm limit. Display the user set upper alarm limit
4 SpO2 lower alarm limit. Display the user set lower alarm limit
5
normalized.
6 Pulse rate value. Display the measured pulse rate per minute.
7
mode. To exit "sleep mode", press [Power] or [Alarm reset] or [Setting]
8 Perfusion Index. Display the measured perfusion index.
9 Pulse rhythm strength.
10 Battery Status
11 Patient type.
12 The unit of SpO2.
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