Bionet BM5 User manual

BM5 User’s Manual
BM5
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.

BM5 User’s Manual
BM5 User Manual
Softwareⓒ Bionet, Co., Ltd. .
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 manuals that are provided with your device carefully.
Patient monitoring equipment, however sophisticated, should never be used as a substitute for
the human care, attention, and critical judgement that only trained health care professionals can
provide.
CAPNOSTAT, LoFlo® is trademark of Respironics.
Masimo®, 및 ISA™ and IRMA™ are trademark of Masimo Corporation.
All other brand or product names are the property of their respective owners.

BM5 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 ......................................................................................................................................................... 42
Overview ........................................................................................................................................................ 42
Network connection ................................................................................................................................ 42
IT Network connection .......................................................................................................................... 43
LAN Network ............................................................................................................................................... 44
VLAN Network ............................................................................................................................................ 44
If you use an inappropriate network ............................................................................................. 44
Remote View ............................................................................................................................................... 45
Display Mode .............................................................................................................................................. 47
4. Admission and Discharge .................................................................................................................... 49
Overview ........................................................................................................................................................ 49
Patient admission ..................................................................................................................................... 49
Patient discharge ...................................................................................................................................... 50
Registration of patient ID using barcode .................................................................................... 55
5. Alarm .............................................................................................................................................................. 56
Overview ........................................................................................................................................................ 56
Alarm priority .............................................................................................................................................. 56
Alarm management ................................................................................................................................. 58
Alarm settings ............................................................................................................................................. 59
Alarm event .................................................................................................................................................. 61
6. Trend ............................................................................................................................................................... 62
Overview ........................................................................................................................................................ 62

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Trend setup .................................................................................................................................................. 62
Graphical trend........................................................................................................................................... 64
Tabular trend ............................................................................................................................................... 66
File export ..................................................................................................................................................... 67
Popup trend ................................................................................................................................................. 69
7. ECG ................................................................................................................................................................... 71
Overview ........................................................................................................................................................ 71
ECG Precaution ........................................................................................................................................... 72
Patient preparation .................................................................................................................................. 75
ECG lead ......................................................................................................................................................... 76
ECG signal processing and display.................................................................................................. 77
ST signal processing and display ..................................................................................................... 78
Alarm and alarm status ......................................................................................................................... 78
Display............................................................................................................................................................. 79
ECG Settings ................................................................................................................................................ 80
Trouble shooting ....................................................................................................................................... 82
8. Arrhythmia Monitoring ......................................................................................................................... 84
Overview ........................................................................................................................................................ 84
Arrhythmia templette ............................................................................................................................. 84
Arrhythmia Settings................................................................................................................................. 86
9. SpO2 ................................................................................................................................................................ 89
Overview ........................................................................................................................................................ 89
Precaution ..................................................................................................................................................... 89
Patient preparation .................................................................................................................................. 90

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Display............................................................................................................................................................. 92
Quality of SPO2 Waveform ................................................................................................................. 93
SPO2 Settings ............................................................................................................................................. 94
Status messages ........................................................................................................................................ 95
10. Respiration ................................................................................................................................................ 97
Overview ........................................................................................................................................................ 97
RESP precaution......................................................................................................................................... 97
Patient Preparation .................................................................................................................................. 98
Display........................................................................................................................................................... 100
RESP Settings ............................................................................................................................................ 100
OxyCRG monitoring ............................................................................................................................... 101
11. NIBP ............................................................................................................................................................ 103
Overview ...................................................................................................................................................... 103
Display........................................................................................................................................................... 106
NIBP Settings ............................................................................................................................................ 107
Measurement Limitations ................................................................................................................... 110
Status Messages ...................................................................................................................................... 112
12. Invasive Blood pressure ................................................................................................................... 113
Overview ...................................................................................................................................................... 113
Precaution ................................................................................................................................................... 117
Display........................................................................................................................................................... 118
IBP settings ................................................................................................................................................ 119
13. EtCO2 ......................................................................................................................................................... 125
Overview ...................................................................................................................................................... 125

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Precaution ................................................................................................................................................... 130
Sampling method ................................................................................................................................... 131
Display........................................................................................................................................................... 133
EtCO2 setup ............................................................................................................................................... 133
Status Message ........................................................................................................................................ 138
14. Temperature ........................................................................................................................................... 141
Overview ...................................................................................................................................................... 141
Display........................................................................................................................................................... 142
Temperature settings ............................................................................................................................ 143
15. Printer ........................................................................................................................................................ 144
Overview ...................................................................................................................................................... 144
Printer settings ......................................................................................................................................... 145
Thermal Paper Storage ........................................................................................................................ 146
Paper Change ............................................................................................................................................ 147
16. Maintenance and Troubleshooting ........................................................................................... 148
Inspection Equipment ........................................................................................................................... 148
Inspection Cables .................................................................................................................................... 148
Maintenance Task and Test Schedule ......................................................................................... 149
Noise in ECG .............................................................................................................................................. 151
SpO2 malfunction ................................................................................................................................... 152
Temperature malfunction ................................................................................................................... 152
NIBP malfunction .................................................................................................................................... 153
Abnormality in NIBP measurements ............................................................................................ 153
EtCO2 malfunction ................................................................................................................................. 154

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Failure in battery recharge ................................................................................................................ 154
Power failure ............................................................................................................................................. 155
Data storage failure ............................................................................................................................... 155
Periodic noises.......................................................................................................................................... 156
Print failure................................................................................................................................................. 156
17. Clean and Care ...................................................................................................................................... 157
Overview ...................................................................................................................................................... 157
Monitor and Peripherals ..................................................................................................................... 157
18. Technical Specification ..................................................................................................................... 162
Overview ...................................................................................................................................................... 162
EMC Compatibility (EMC) ................................................................................................................... 162
Manufacturer’s declaration - electromagnetic emission................................................... 164
Manufacturer’s declaration - electromagnetic immunity ................................................. 165
Guidance and manufacturer’s declaration - electromagnetic immunity ................. 171
System Specification ............................................................................................................................. 173
Adult & Pediatric - ICU Mode ................................................................................................................. 179
Alarm level .................................................................................................................................................. 179
Neonate-ICU Mode ...................................................................................................................................... 180
Alarm level .................................................................................................................................................. 180
Parameter Limits .......................................................................................................................................... 182
Display ............................................................................................................................................................... 184
Abbreviations and Symbols ................................................................................................................... 185
PRODUCT WARRANTY ............................................................................................................................. 189
International Sales & Service Contact .............................................................................................. 190

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Intended Use
The BM5 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 BM5 monitor can monitor the following:
 Heart Rate
 Respiration Rate
 Invasive blood pressure
 Non-Invasive blood pressure
 Arrhythmia
 Temperature
 SpO2
 Pulse Rate
 Apnea
 ST segment analysis
 EtCO2
 FiO2
This equipment is designed to be used in an environment where a health care

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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.
Patient Classification
BM5 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 electromedical 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
VF9 Delta/Delta XL/Kappa 19

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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 BM5 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
BM5 is classified as follows:
- BM5 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; 1996.
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 BM5 Monitor 1 EA
2. 5-Lead patient 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. IBP Transducer Set (Disposable/Reusable)
3. Sidestream EtCO2 Module (Respironics)
4. Mainstream EtCO2 Module (Respironics)
5. Sidestream EtCO2 airway adapter sampling kit
6. Mainstream EtCO2 airway adapter
7. 3-Lead Patient Cable (MECA3-US, MECA3-EU)
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
6 IBP connector