Bionet BM1 User manual

Rev. 2.2 1
BM1
User’s Manual
Patient Monitor
Rev. 2.2
2021.05.04
BM1 Vital-Sign Monitor
Warning
To ensure proper use of this medical equipment, you must read and comply with this user manual.

Rev. 2.2 2
BM1 User Manual
Copyrightⓒ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.
All other brand or product names are the property of their respective owners.
Document No: BN-OP-BM1

Rev. 2.2 3
Table of Contents
BM1 User Manual
Intended Use ....................................................................................................................................................... 8
General Description ......................................................................................................................................... 8
Patient Classification ...................................................................................................................................... 9
Functional Safety .............................................................................................................................................. 9
Warning, Caution, Note ............................................................................................................................. 10
Define Groups ................................................................................................................................................. 11
General Precaution on Environment ................................................................................................... 12
Electromagnetic Compatibility ............................................................................................................... 13
1. Basic ................................................................................................................................................................ 15
Basic Overview ............................................................................................................................................. 15
Electric Safety Precautions ...................................................................................................................... 15
Equipment Connection ............................................................................................................................. 17
Biocompatibility ........................................................................................................................................... 17
Product Configuration .............................................................................................................................. 17
Option Product ............................................................................................................................................ 18
Basic Unit ........................................................................................................................................................ 19
Device Markings .......................................................................................................................................... 25
Power ................................................................................................................................................................ 26

Rev. 2.2 4
Battery Power ............................................................................................................................................... 27
Getting Started............................................................................................................................................. 32
2. Setup ............................................................................................................................................................... 36
Setup Overview ............................................................................................................................................ 36
Monitor Configuration .............................................................................................................................. 36
Main Menu Settings .................................................................................................................................. 37
3. Network ......................................................................................................................................................... 43
Network Overview ...................................................................................................................................... 43
Network Connection ................................................................................................................................. 43
IT Network Connection ............................................................................................................................ 46
LAN Network ................................................................................................................................................ 47
VLAN Network.............................................................................................................................................. 47
When Using an Inappropriate Network ........................................................................................... 48
4. Patient ............................................................................................................................................................ 49
Patient Overview ......................................................................................................................................... 49
Continuous Mode ....................................................................................................................................... 49
Spot / Triage Mode ................................................................................................................................... 50
Patient Settings ............................................................................................................................................ 52
5. ALARM ........................................................................................................................................................... 56
ALARM Overview ........................................................................................................................................ 56
ALARM Priority ............................................................................................................................................. 56
ALARM Management ................................................................................................................................ 58
ALARM Settings ........................................................................................................................................... 60

Rev. 2.2 5
6. EWS(Early Warning Score) .................................................................................................................. 63
EWS Overview .............................................................................................................................................. 63
How to Use EWS ......................................................................................................................................... 64
7. TREND ............................................................................................................................................................ 67
TREND Overview ......................................................................................................................................... 67
Continuous Mode ....................................................................................................................................... 67
File Export ....................................................................................................................................................... 70
Spot / Triage Mode ................................................................................................................................... 72
8. SpO2 ................................................................................................................................................................ 77
SpO2 Overview ............................................................................................................................................ 77
SpO2 Precautions ....................................................................................................................................... 77
SpO2 Patient Preparation........................................................................................................................ 78
SpO2 Connector and Measurement Cable ..................................................................................... 79
SpO2 Display................................................................................................................................................. 80
SpO2 Signal and Data Validity ............................................................................................................. 81
SpO2 Settings ............................................................................................................................................... 83
SpO2 Status Messages ............................................................................................................................. 83
9. NIBP ................................................................................................................................................................. 85
NIBP Overview .............................................................................................................................................. 85
NIBP Precautions ......................................................................................................................................... 85
NIBP Patient Preparation ......................................................................................................................... 87
NIBP Connector and Measurement Cable ...................................................................................... 89
NIBP Display .................................................................................................................................................. 91

Rev. 2.2 6
NIBP Settings ................................................................................................................................................ 92
NIBP Status Messages .............................................................................................................................. 93
10. EtCO2 ........................................................................................................................................................... 95
EtCO2 Overview ........................................................................................................................................... 95
EtCO2 Precautions ...................................................................................................................................... 95
EtCO2 Connector And Accessories ..................................................................................................... 97
EtCO2 Connecting and Sampling Method .................................................................................... 101
EtCO2 Display ............................................................................................................................................. 103
EtCO2 Settings ........................................................................................................................................... 103
EtCO2 Status Messages ......................................................................................................................... 108
EtCO2 Measurement Failure ............................................................................................................. 109
11. Temperature ........................................................................................................................................... 110
Temperature Overview ........................................................................................................................... 110
Temperature Connector and Measurement Cable .................................................................... 110
Temperature Display ............................................................................................................................... 113
How to Take a Temperature ................................................................................................................ 114
Temperature Settings .............................................................................................................................. 115
12. Maintenance and Troubleshooting ........................................................................................... 116
Inspection Equipment ............................................................................................................................. 116
Inspection Cables ...................................................................................................................................... 116
Maintenance Task and Test Schedule ............................................................................................. 117
Troubleshooting ........................................................................................................................................ 118
Storage lifetime issues ......................................................................................................................... 122

Rev. 2.2 7
13. Clean and Care ...................................................................................................................................... 123
Clean and Care Overview ...................................................................................................................... 123
Monitor and Peripherals ........................................................................................................................ 123
14. Technical Specification ..................................................................................................................... 127
Technical Specification Overview ....................................................................................................... 127
EMC Compatibility (EMC) ...................................................................................................................... 127
Manufacturer’s Declaration - Electromagnetic Emission ........................................................ 129
Manufacturer’s Declaration - Electromagnetic Immunity ....................................................... 129
System Specification ................................................................................................................................ 131
Default Alarm Level .................................................................................................................................. 134
Parameter Limit .......................................................................................................................................... 134
Default Display ........................................................................................................................................... 135
Abbreviations .............................................................................................................................................. 136
Symbols ......................................................................................................................................................... 139

Rev. 2.2 8
Intended Use
The BM1 monitor is for patient vital-sign monitoring. The instrument generates visual and audible
alarms, when the configured limits and time are exceeded, or when various physiological parameters
are monitored.
NOTE
All hardware and screenshots in this user guide are for illustration purposes only. Actual
products or screens may vary slightly.
General Description
The BM1 monitor can monitor the following:
 Non-Invasive blood pressure
 Temperature
 SpO2
 Pulse Rate
 Apnea (option)
 EtCO2 (option)
 FiCO2 (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.

Rev. 2.2 9
Patient Classification
BM1 monitors are designed for use by adults, pediatrics and neonates.
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.

Rev. 2.2 10
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.

Rev. 2.2 11
Define Groups
The defined groups for this product are users, service personnel, and experts.
Defined 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 expert repairs the product or performs complex maintenance tasks.
The expert have the knowledge and experience to perform complex maintenance tasks on the
product.

Rev. 2.2 12
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.

Rev. 2.2 13
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, CISPR 11 Class A.
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.

Rev. 2.2 14
CAUTION
Infectious devices and parts must be sanitized and cleaned before disposal.

Rev. 2.2 15
1. Basic
Basic Overview
This Vital-sign monitor is for adult, pediatric, and neonatal monitoring. It can be used as an
independent device or connected to EMR network. Use of the monitor is limited to one patient at
a time.
The following optional software features are available:
 Connecting EMR server.
 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.
(Manufacturer : BRIDGEPOWER, Model: JMW128, Rated Voltage: DC15V/2.0A)
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.

Rev. 2.2 16
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 BM1 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
BM1 is classified as follows :
 BM1 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 noise 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.

Rev. 2.2 17
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 BM1 Monitor 1 EA
2. NIBP Extended Hose 1 EA
3. Reusable Adult NIBP Cuff 1 EA
4. SpO2 extension cable 1 EA
5. Reusable Adult SpO2 Probe 1 EA
6. DC Adaptor 1 EA
7. User Manual 1 EA
8. Rechargeable Battery 1 EA

Rev. 2.2 18
Option Product
1. Temperature (IR Thermometer, FS-300)
2. Sidestream EtCO2 Module (Respironics)
3. Mainstream EtCO2 Module (Respironics)
4. Sidestream EtCO2 airway adapter sampling kit
5. Mainstream EtCO2 airway adapter
6. Barcode Reader (USB)
7. Cart and Cradle
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.

Rev. 2.2 19
Basic Unit
Front View
① Alarm lamp
② Battery operation indicator
③ AC status indicator
①
③
②

Rev. 2.2 20
Right Side View
① Alarm control key
② Blood-pressure measurement key
③ Operation mode/ home key
④ Power ON/OFF Key
⑤ SpO2 connector
⑥ Infra-Temperature connector
⑦ Blood pressure cuff hose connector
⑧ EtCO2 connector
①
②
④
⑤
③
⑥
⑦
⑧