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

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: [phone]

Fax: [phone]

Revision R01

June, 2019

Printed in Korea

Copyright © Bistos Corporation 2018. All rights reserved.

P/N : 710-ENG-OPM-EUR-R01	Bistos Co., Ltd.	2019.06

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Contents

0.Safety information ······················································································· 4

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

0.2Shock hazards ············································································································· 8

0.3Battery warnings········································································································· 9

0.4General precautions on environment ······································································· 10

1.System basics ······························································································· 11

1.1Intended use ··············································································································· 11

1.2Operating principle ····································································································· 12

1.3System configurations ································································································ 12

1.4Product outlook ·········································································································· 12

1.5Description of pulse oximeter ···················································································· 14

1.6Understanding the display ························································································· 16

1.7Essential performance ································································································ 17

2.Preparing for operation ················································································ 18

2.1Installation ·················································································································· 18

2.2Connecting to power ·································································································· 19

3.Basic operations ··························································································· 20

3.1Turn on ························································································································ 20

3.2Turn off ······················································································································· 21

4.Setup the pulse oximeter ············································································· 22

5.SpO2 ············································································································ 25

5.1Overview ····················································································································· 25

5.2Safety information ····································································································· 25

5.3Monitoring steps ········································································································ 26

5.4Setting SpO2 ················································································································ 27

5.5Measuring influencing factors ···················································································· 29

5.6 Technical Description ································································································ 29

6.Review ········································································································ 31

7.Alarm ·········································································································· 33

7.1Alarm types ··············································································································· 33

7.2Alarm condition priorities ························································································· 33

7.3Alarm mode ·············································································································· 34

7.4Alarm state ················································································································ 35

7.5Alarm information ····································································································· 36

8.Battery ········································································································ 38

8.1Overview ····················································································································· 38

8.2Battery usage guide····································································································· 38

8.3Checking battery performance ·················································································· 39

8.4Battery recycling ········································································································· 40

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9.Caring and cleaning ······················································································ 41

9.1Overview ····················································································································· 41

9.2Cleaning ······················································································································ 41

9.3Disinfection ················································································································ 42

10.Maintenance ································································································ 43

10.1Checking ··················································································································· 43

10.2Trouble shootings ····································································································· 44

10.3Maintenance plan ···································································································· 44

11.Accessories ·································································································· 45

12.Specifications ······························································································· 46

12.1Safety specification ·································································································· 46

12.2Hardware specifications ··························································································· 46

12.3Functional specification ··························································································· 47

13.Manufacturer’s declaration on EMC ····························································· 48

13.1Electromagnetic emissions ······················································································· 49

13.2Recommended separation distances between portable and mobile RF communications equipment and BT-710 ····································································································· 50

13.3Electromagnetic 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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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:

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:

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

Indicates the protection level against the ingress of liquid.

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

It correspond the device and the accessory for SpO2.

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 manufacturer.

Indicates a BF applied part.

Indicates CLASS II equipment.(Adapter)

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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 temperature limitation for operation, transport and 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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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.

WARNING

•Thoroughly read and understand the manual prior to use of the BT-710. Failure 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 regulations or hospital waste disposal regulations. Keep the 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 pulse oximeter 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

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displayed on the pulse oximeter 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.

•Use of accessories other than 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 pulse oximeter is located. Textiles, oils, and other combustibles are easily 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 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-710 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 pulse oximeter 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 pulse oximeter in the environment such as pressure is too high,

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poor ventilation, dusty, or contain salt, sulfur gas and chemical.

•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.

•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 this manual.

•Equipment should be tested at least once a year, the test should be done and recorded by trained, have safety 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 pulse oximeter. The operation or use of non-approved equipment or accessories with the pulse oximeter is not tested or supported, and pulse oximeter 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.

0.2 Shock hazards

WARNING

Unplug the pulse oximeter 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

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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 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

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 pulse oximeter under the environment listed below.

	Avoid placing in an area		Avoid exposure to direct
	exposed to moisture. Do
	not touch the pulse		sunlight
	oximeter 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 enters
	stored or where there is
			into the pulse oximeter.
	in danger of gas leakage.
	Do not disjoint or		Power off when the pulse
			oximeter is not fully
	disassemble the pulse
			ready to operate.
	oximeter. Bistos Co., Ltd.
			Otherwise, the pulse
	does not have liability of
			oximeter could be
	it.
			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 (SpO2) and pulse rate (PR). 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 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 SpO2 sensor probe

•AC/DC adapter

1.4 Product outlook

Figure1-1: Front view

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Figure1-2 : Rear view

Figure1-3 : Top view

Figure1-4 : Bottom view

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1.5 Description of pulse oximeter

			Figure1-5: Front view
		Name	Description
	1	DC power indicator	Turned on when the pulse oximeter is being powered by
			the adapter.
	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”.
	4	[Alarm reset]	To reset the alarm condition.
	5		Enter to the setting mode. Press again to close the setting
		[Setting]	mode.

P/N : 710-ENG-OPM-EUR-R01	Bistos Co., Ltd.	2019.06

BT-710 Operation manual	15

		Figure1-6: Top view
	Name		Description
6	SpO2		SpO2 sensor probe interface

		Figure1-7: Bottom view
	Name		Description
7	SD card interface		For software upgrade
8	Power adapter		5V, 2A adapter
9	Lanyard eyelet		For convenient hand held

P/N : 710-ENG-OPM-EUR-R01	Bistos Co., Ltd.	2019.06

BT-710 Operation manual	16

1.6 Understanding the display

Figure 1-8: Standard display

Description

1Current alarm message. When an alarm occurs, this area will displayed yellow or red depending on the alarm type.

2SpO2 value. Display the measured SpO2 value.

3SpO2 upper alarm limit. Display the user set upper alarm limit

4SpO2 lower alarm limit. Display the user set lower alarm limit

5SpO2 waveform. Display the measured SpO2 waveform. The waveform is not normalized.

6Pulse rate value. Display the measured pulse rate per minute.

7Sleep mode. Touch this area makes the pulse oximeter to enter the sleep mode. To exit "sleep mode", press [Power] or [Alarm reset] or [Setting]

8Perfusion Index. Display the measured perfusion index.

9Pulse rhythm strength.

10Battery Status

11Patient type.

12The unit of SpO2.

P/N : 710-ENG-OPM-EUR-R01	Bistos Co., Ltd.	2019.06