Bionet BM3 User manual

BM3 User’s Manual
BM3
User’s Manual
Patient Monitor
Rev. 3.0
2019.11.22
Warning
To ensure proper use of this medical equipment, you must read and comply with this user manual.

BM3 User’s Manual
BM3 User Manual
Softwareⓒ Bionet, Co., Ltd. 2016.
All rights reserved.
Reproduction in any manner, in whole or in part, except for brief excerpts in reviews and scientific
papers, is prohibited without prior written permission of Bionet, Co., Ltd.
Before using Bionet devices, read all the manual that are provided with your device carefully.
Patient monitoring equipment, regardless of the complexity of the equipment, should never be
used as a substitute for the patient care, attention, and critical judgment that only trained health
care professionals can provide.
CAPNOSTAT, LoFlo® is trademark of Respironics.
All other brand or product names are the property of their respective owners.

BM3 User’s Manual
Table of Contents
Intended Use ....................................................................................................................................................... 9
General Description ......................................................................................................................................... 9
Patient Classification ................................................................................................................................... 10
Functional safety ............................................................................................................................................ 10
Warning, Caution, Note ............................................................................................................................. 11
Define groups .................................................................................................................................................. 12
General precaution on environment ................................................................................................... 13
Electromagnetic Compatibility ............................................................................................................... 14
1. Basic ................................................................................................................................................................ 15
Overview ........................................................................................................................................................ 15
Electric safety precautions ................................................................................................................... 15
Biocompatibility ......................................................................................................................................... 17
Product Configuration............................................................................................................................ 17
Option Product ........................................................................................................................................... 18
Basic Unit ....................................................................................................................................................... 19
Device Markings ........................................................................................................................................ 24
Power ............................................................................................................................................................... 25
How to replace the battery ................................................................................................................. 29
Getting Started ........................................................................................................................................... 31
2. SETUP .............................................................................................................................................................. 34
Overview ........................................................................................................................................................ 34

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Monitor configuration ............................................................................................................................ 34
Main menu setup ...................................................................................................................................... 35
3. Network ......................................................................................................................................................... 41
Overview ........................................................................................................................................................ 41
Network connection ................................................................................................................................ 41
Remote View ............................................................................................................................................... 42
Display Mode .............................................................................................................................................. 44
4. Admission and Discharge .................................................................................................................... 46
Overview ........................................................................................................................................................ 46
Patient admission ..................................................................................................................................... 46
Patient discharge ...................................................................................................................................... 47
Registration of patient ID using barcode .................................................................................... 52
5. Alarm .............................................................................................................................................................. 53
Overview ........................................................................................................................................................ 53
Alarm priority .............................................................................................................................................. 53
Alarm management ................................................................................................................................. 55
Alarm settings ............................................................................................................................................. 56
Alarm event .................................................................................................................................................. 57
6. TREND ............................................................................................................................................................ 58
Overview ........................................................................................................................................................ 58
Trend setup .................................................................................................................................................. 58
Graphical trend........................................................................................................................................... 61
Tabular trend ............................................................................................................................................... 62
File export ..................................................................................................................................................... 63
Popup trend ................................................................................................................................................. 65

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7. ECG ................................................................................................................................................................... 67
Overview ........................................................................................................................................................ 67
ECG Precaution ........................................................................................................................................... 68
Patient preparation .................................................................................................................................. 71
ECG lead ......................................................................................................................................................... 72
ECG signal processing and display.................................................................................................. 73
ST signal processing and display ..................................................................................................... 74
Alarm and alarm status ......................................................................................................................... 74
Display............................................................................................................................................................. 75
ECG Settings ................................................................................................................................................ 75
Trouble shooting ....................................................................................................................................... 78
8. Arrhythmia Monitoring(*) ................................................................................................................... 80
Overview ........................................................................................................................................................ 80
Arrhythmia templette ............................................................................................................................. 80
Arrhythmia Settings................................................................................................................................. 81
9. SpO2 ................................................................................................................................................................ 83
Overview ........................................................................................................................................................ 83
Precaution ..................................................................................................................................................... 83
Patient preparation .................................................................................................................................. 84
Display............................................................................................................................................................. 85
Quality of SPO2 Waveform ................................................................................................................. 87
SPO2 Settings ............................................................................................................................................. 88
Status messages ........................................................................................................................................ 89
10. RESPIRATION ........................................................................................................................................... 90
Overview ........................................................................................................................................................ 90

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RESP precaution......................................................................................................................................... 90
Patient Preparation .................................................................................................................................. 91
Display............................................................................................................................................................. 93
RESP Settings .............................................................................................................................................. 94
OxyCRG monitoring ................................................................................................................................. 94
11. NIBP .............................................................................................................................................................. 97
Overview ........................................................................................................................................................ 97
Display............................................................................................................................................................. 99
NIBP Settings ............................................................................................................................................ 100
Measurement Limitations ................................................................................................................... 103
Status Messages ...................................................................................................................................... 105
12. EtCO2(*) .................................................................................................................................................... 106
Overview ...................................................................................................................................................... 106
Precaution ................................................................................................................................................... 111
Sampling method ................................................................................................................................... 112
Display........................................................................................................................................................... 114
EtCO2 setup ............................................................................................................................................... 114
Status Message ........................................................................................................................................ 119
13. Temperature ........................................................................................................................................... 122
Overview ...................................................................................................................................................... 122
Display........................................................................................................................................................... 123
Temperature settings ............................................................................................................................ 124
14. Printer ........................................................................................................................................................ 125
Overview ...................................................................................................................................................... 125
Printer settings ......................................................................................................................................... 126

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Thermal Paper Storage ........................................................................................................................ 128
Paper Change ............................................................................................................................................ 129
15. Maintenance and Troubleshooting ........................................................................................... 130
Inspection Equipment ........................................................................................................................... 130
Inspection Cables .................................................................................................................................... 130
Maintenance Task and Test Schedule ......................................................................................... 131
Noise in ECG .............................................................................................................................................. 133
SpO2 malfunction ................................................................................................................................... 134
Temperature malfunction ................................................................................................................... 134
NIBP malfunction .................................................................................................................................... 135
Abnormality in NIBP measurements ............................................................................................ 135
EtCO2 malfunction ................................................................................................................................. 136
Failure in battery recharge ................................................................................................................ 136
Power failure ............................................................................................................................................. 137
Data storage failure ............................................................................................................................... 137
Periodic noises.......................................................................................................................................... 138
Print failure................................................................................................................................................. 138
16. Clean and Care ...................................................................................................................................... 139
Overview ...................................................................................................................................................... 139
Monitor and Peripherals ..................................................................................................................... 139
17. Technical Specification ..................................................................................................................... 143
Overview ...................................................................................................................................................... 143
EMC Compatibility (EMC) ................................................................................................................... 143
Manufacturer’s declaration - electromagnetic emission................................................... 145
Manufacturer’s declaration - electromagnetic immunity ................................................. 146

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Guidance and manufacturer’s declaration - electromagnetic immunity ................. 152
System Specification ............................................................................................................................. 154
Adult & Pediatric-ICU Mode ................................................................................................................... 160
Alarm level .................................................................................................................................................. 160
Neonate-ICU Mode ...................................................................................................................................... 161
Alarm level .................................................................................................................................................. 161
Parameter Limits .......................................................................................................................................... 162
Display ............................................................................................................................................................... 163
Abbreviations and Symbols ................................................................................................................... 164
PRODUCT WARRANTY ............................................................................................................................. 169
International Sales & Service Contact .............................................................................................. 170

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Intended Use
The BM3 monitor is for multi-parameter patient monitoring. The instrument generates
visual and audible alarms when a variety of physiological parameters are monitored over
a present limit and time, or where recording begins. This equipment is connected via BM
central.
Note
All Bionet hardwares and screenshots in this user guide are for illustration purposes only.
Actual products or screens may vary slightly.
General Description
The BM3 monitor can monitor the following:
 Heart Rate
 Respiration Rate
 Non-Invasive blood pressure
 Arrhythmia
 Temperature
 SpO2
 Pulse Rate
 Apnea
 ST segment analysis
 EtCO2(option)
 FiO2(option)
This equipment is designed to be used in an environment where a health care
professional can determine when to use the equipment for its intended purpose, based
on an expert assessment of the patient's medical condition, including physicians, nurses.

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Patient Classification
BM3 monitors are designed for use by adults, pediatrics and neonates. At this time,
cardiac output, ST segment analysis and arrhythmia should be used for adults and
pediatrics only.
Functional safety
The essential performance of the patient monitor is to provide the clinician with
meaningful parameter values and to sound an alarm when the established parameter
value is exceeded or the function that provides the value is not working properly. We
assessed the risks associated with the use of these monitors in light of these essential
performance features and mitigated the risk of lowering the residual risk to a level that
could be used without compromise as long as the product maintained its regular
lifecycle maintenance and service recommendations.

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Warning, Caution, Note
The following terms are defined in the User Guide to emphasize the agreement as
follows:
The user must follow all warnings and precautions.
The specifications and functions shown in this manual are subject to change without
prior notice.
Warning
“Warning” A warning contains important information regarding possible danger to
you or the patient that is present during normal operation of the equipment
Caution
“Caution” A caution provides information or instructions that must be followed to
ensure proper operation and performance of the equipment.
Note
“Note” A note presents information that helps you operate the equipment or
connected devices.

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Define groups
The define groups for this product are users, service personnel, and experts.
Define groups should read the user manual before using the product and be trained in
the use, installation, reprocessing, maintenance and repair of the product.
This product can only be used, installed, reprocessed, maintained and repaired by a
defined group.
User
Users use the product for their intended use.
Service personnel
Service personnel are responsible for the maintenance of the product.
They must be trained in the maintenance of the medical device, install, reprocess and
maintain the product.
Expert
The specialist repairs the product or performs complex maintenance tasks. The expert
Have the knowledge and experience to perform complex maintenance tasks on your
product.

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General precaution on environment
- Do not keep or operate the equipment in the environment listed below.
Avoid placing in an area
exposed to moist.
Do not touch the
equipment with wet
hand.
Avoid exposure to
direct sunlight
Avoid placing in an area
where there is a high
variation of temperature.
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 there is
an excessive shock
or vibration.
Avoid placing in an area
where chemicals are
stored or where there is
danger of gas leakage.
Avoid being
inserted dust and
especially metal
material into the
equipment
Do not disjoint or
disassemble the
equipment.
We take no
responsibility for it.
Power off when the
equipment is not
fully installed.
Otherwise,
equipment could be
damaged.

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Electromagnetic Compatibility
The monitor has been designed and tested for compliance with current regulatory
standards as to its capacity to limit electromagnetic emissions(EMI), and also as to its
ability to block the effects of EMI from external sources.
The monitor complies with the following standards pertaining to EMI emissions and
susceptibility: EN60601-1-2.
To reduce possible problems caused by electromagnetic interference, we recommend the
following:
 Use only Bionet approved accessories.
 Ensure that other products used in areas where patient monitoring and life
support is used comply to accepted emissions standards (CISPR 11, Class A).
 Try to maximize the distance between electro-medical devices. High-power
equipment related to electrical simulators, electrosurgical instruments and
radiators (X-ray machines) as well as evoked potential devices may cause monitor
interference.
 Strictly limit exposure and access to portable radio frequency sources (e.g.
cellular phones and radio transmitters). Be aware that portable phones may
periodically transmit even when in standby mode.
 Maintain good cable management. Do not route cables over electrical equipment.
Do not intertwine cables.
 Ensure all electrical maintenance is performed by qualified personnel.
Caution
Infectious devices and parts must be sanitized and cleaned before disposal.
사용 안내서

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1. Basic
Overview
This patient monitor is for adult, pediatric, and neonatal monitoring. It can be used as an
independent device or connected to the BM Central network. Use of the monitor is
limited to one patient at a time.
The following optional software features are available:
 Arrhythmia analysis.
 3-lead ST segment analysis.
 It is common to connect B2B VIEWs, and the two connections are optional.
 Wireless network connection
Electric safety precautions
Caution
Please check the following before using the product.
1. Be sure that AC power supply line is appropriate to use. (AC100 - 240V)
2. Be sure that the power source is the one supplied from Bionet.(DC18V, 2.8A, BPM050
Made in BridgePower Co., Ltd.)
3. Be sure that the entire connection cable of the system is properly and firmly fixed.
4. Be sure that the equipment is completely grounded.(If not, there might be the
problem occur in the product.)
5. The equipment should not be placed in the vicinity of electric generator, X-ray,
broadcasting apparatus to eliminate the electric noise during operation. Otherwise, it
may cause incorrect result.

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Caution
The Equipment should be placed far from generator, X-ray equipment, broadcasting
equipment or transmitting wires, so as to prevent the electrical noises from being
generated during the operation, When these devices are near the Equipment, it can
produce inaccurate measurements. For BM3 both independent circuit and stable
grounding are essentially required. In the event that the same power source is
shared with other electronic equipment, it can also produce inaccurate output.
Note
BM3 is classified as follows:
- BM3 classifies as Class II, BF & CF concerning electric shock. It is not proper to
operate this Equipment around combustible anesthetic or dissolvent.
- Noise level is A class regarding IEC/EN 60601-1 and the subject of Nose is A level
concerning IEC/EN60601-1-2.
Warning
Do not touch the patient while using the defibrillator. The user may be at risk.
When using the defibrillator, be careful about safety and use only the supplied
cable.
Warning
In case the Equipment does not operate as usual or damaged, do not use on
patient, and contact to the medical equipment technician of the hospital or the
equipment supply division.

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Equipment connection
Caution
Doctors and patients in hospitals are exposed to the risk of uncontrollable currents.
This current is caused by a potential difference between the equipment and a
conductive object that can be contacted. Use auxiliary equipment to meet this
requirement in accordance with EN60601-1; 2011.
Biocompatibility
When used as intended, the parts of the product described in this operator manual,
including accessories that come in contact with the patient during the intended use,
fulfill the biocompatibility requirements of the applicable standards. If you have
questions about this matter, please contact Bionet or its representatives.
Product Configuration
1. Main body of BM3 Monitor 1 EA
2. 3-Lead Patient Cable with extension cable 1EA
3. Disposable electrodes 10 EA
4. NIBP extension horse 1EA
5. Reusable Adult NIBP Cuff 1EA
6. SpO2 extension cable 1EA
7. Reusable Adult SpO2 Probe 1 EA
8. DC Adaptor (BPM050S18F02 made in Bridgepower Co., Ltd.) 1 EA
9. Operator`s Manual 1 EA
10. Thermal roll Paper 2 ROLL

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Option Product
1. Reusable Temperature Probe (Surface/Skin, TEMPSENS-430)
2. Sidestream EtCO2 Module (Respironics)
3. Mainstream EtCO2 Module (Respironics)
4. Sidestream EtCO2 airway adapter sampling kit
5. Mainstream EtCO2 airway adapter
6. 5-Lead Patient Cable with extension cable
Warning
In order to avoid electrical shock, do not open the cover. Disassembling of the
equipment should be done only by the service personnel authorized by Bionet
Warning
Users must pay attention on connection any auxiliary device via LAN port or nurse
calling. Always consider about summation of leakage current, please check if the
auxiliary device is qualified by IEC 60601-1, or consult your hospital biomedical
engineer.

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Basic Unit
Front view
1 Alarm lamp handle 5 Home key
2 Alarm control key 6 Rotary knob key
3 Printer key 7 Power ON/OFF Key
4 Blood-pressure measurement key 8 Battery status indicator
1
8
2
3
4
5
6
7

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Right side view
1 ECG connector
2 Blood pressure Hose connector
3 SpO2 connector
4 Temperature connector
5 EtCO2 connector