Bionet BM1 User manual

BM1 User’s Manual
BM1 User’s Manual
Patient Monitor
Rev. 1.4

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Table of Contents
BM1 User’s Manual ............................................................................0
Table of Contents............................................................................................................... 1
B A S I C............................................................................................10
1.1 CE Standard Information ...........................................................................................11
1.2 Read before Use......................................................................................................... 13
How to Contact Us .......................................................................................................... 13
Warranty Period .............................................................................................................. 14
Warning, Caution, Note................................................................................................... 15
General Precaution on Environment............................................................................... 16
General Precautions on Electrical Safety....................................................................... 21
Cleaning Applied Parts.................................................................................................... 23
1.3 Product Components ................................................................................................ 25
Product Outline................................................................................................................ 25
Principal Characters of Product...................................................................................... 25
Product Configuration ..................................................................................................... 26
Optional Products............................................................................................................ 26
Product Body Configuration............................................................................................ 27
Accessories..................................................................................................................... 29
Equipment Sign............................................................................................................... 30
DC Power Input port.........................................................................31
1.4 Function and Key....................................................................................................... 33
External Function ............................................................................................................ 33
Operation Key ................................................................................................................. 33
1.5 Standard Power Supply Application ....................................................................... 34
DC Power........................................................................................................................ 34
1.6 Battery Power Supply Application........................................................................... 35
Operation......................................................................................................................... 35
The Impact of Lithium-Ion Battery Technology on the Battery....................................... 37
Conditioning Guideline .................................................................................................... 37
Storage Guideline............................................................................................................ 37

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How to Recycle the Battery............................................................................................. 37
1.7 DISPLAY MODE ( MONITOR OR SPOT )................................................................. 38
MONITORING MODE ........................................................................39
1. General Operation........................................................................40
1.1 General Manu Operation........................................................................................... 40
Screen Composition........................................................................................................ 40
Menu Selection................................................................................................................ 41
Menu Composition .......................................................................................................... 41
2. PATIENT/DATA MANAGEMENT....................................................45
2.1 ADMIT.......................................................................................................................... 46
ADMIT TYPE................................................................................................................... 46
CHANGE ADMIT INFO................................................................................................... 47
DISCHARGE ( Discharge Patient )................................................................................. 49
ADMIT ( Admit patient )................................................................................................... 49
HEIGHT........................................................................................................................... 50
WEIGHT.......................................................................................................................... 50
2.2 ALARM........................................................................................................................ 51
Alarm for the Product ...................................................................................................... 51
Alarm ICON..................................................................................................................... 52
ALL LIMITS...................................................................................................................... 53
ALARM VOLUME............................................................................................................ 54
ALARM LEVEL................................................................................................................ 54
PARAMETER LEVEL...................................................................................................... 55
PARAMETER ALARM LEVEL2...................................................................................... 55
ALARM REVIEW............................................................................................................. 56
ALARM LIST.................................................................................................................... 56
SAVE CONDITION.......................................................................................................... 57
NURSE CALL.................................................................................................................. 58
3. SETUP...........................................................................................59
3.1 SETUP......................................................................................................................... 60
DISPLAY ......................................................................................................................... 60
SET PARA....................................................................................................................... 61

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SET DATE & TIME.......................................................................................................... 61
SET TIME........................................................................................................................ 61
SET DATE....................................................................................................................... 62
SWEEP SPEED.............................................................................................................. 62
DEMO.............................................................................................................................. 63
USB FILE COPY............................................................................................................. 63
USER SERVICE.............................................................................................................. 66
SET UNIT NAME............................................................................................................. 66
SET BED NUMBER........................................................................................................ 67
AC FILTER...................................................................................................................... 67
W-LAN............................................................................................................................. 68
DISPLAY MODE ( MONITOR or SPOT )....................................................................... 68
SYSTEM.......................................................................................................................... 68
KEY SOUND ................................................................................................................... 69
MAKER SERVICE........................................................................................................... 69
4. TREND...........................................................................................70
4.1 TREND......................................................................................................................... 71
GRAPHIC TREND........................................................................................................... 72
TIME PERIOD................................................................................................................. 73
TABULAR TREND.......................................................................................................... 74
TIME INTERVAL............................................................................................................. 74
5. SpO2..............................................................................................75
5.1 Outline......................................................................................................................... 76
SpO2 Connector Location and Measuring Cable........................................................... 76
5.2 SpO2 Data Window.................................................................................................... 77
Signal and Data Validity.................................................................................................. 78
5.3 SpO2Data Setup ........................................................................................................ 80
RATE VOLUME............................................................................................................... 80
ALARM............................................................................................................................ 81
ALARM LIMIT.................................................................................................................. 81
ALARM SOUND.............................................................................................................. 82
5.4 TROUBLE SHOOTING............................................................................................... 83
LEAD FAULT Condition.................................................................................................. 83

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SPO2 Messages ............................................................................................................. 83
6. NIBP ..............................................................................................84
6.1 Outline......................................................................................................................... 85
6.2 NIBP Data Window..................................................................................................... 87
6.3 NIBP Data Setup......................................................................................................... 88
ALARM............................................................................................................................ 88
ALARM LIMIT.................................................................................................................. 89
ALARM SOUND.............................................................................................................. 90
CUFF SIZE...................................................................................................................... 90
UNIT SELECT................................................................................................................. 91
INTERVAL....................................................................................................................... 91
INFLATION...................................................................................................................... 92
6.4 TROUBLESHOOTING................................................................................................ 93
NIBP Status Messages ................................................................................................... 93
Erroneous NIBP measurement....................................................................................... 94
7. TEMPERATURE ............................................................................95
7.1 Outline......................................................................................................................... 96
7.2 Temperature Data Window ....................................................................................... 97
7.3 Temperature Data Setup........................................................................................... 98
ALARM............................................................................................................................ 98
ALARM LIMIT.................................................................................................................. 99
ALARM SOUND............................................................................................................100
UNIT SELECT...............................................................................................................100
7.4 TROUBLESHOOTING..............................................................................................101
Check list.......................................................................................................................101
TEMP Message.............................................................................................................101
8. EtCO2..........................................................................................102
8.1 Introduction.............................................................................................................. 103
8.2 EtCO2 Parameter Window ......................................................................................108
8.3 EtCO2 Parameter Setting Menu .............................................................................109
ALARM LIMIT(Upper/lower limit value of alarm)..........................................................109

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ALARM SOUND............................................................................................................110
EtCO2 SWEEP SPEED................................................................................................111
WAVEFORM SCALE (Measured waveform scale setting) ..........................................111
SETUP (Various setting)...............................................................................................112
APNEA DETECT...........................................................................................................115
8.4 TROUBLESHOOTING...............................................................................................119
9. DEFAULT SETTING VALUE........................................................120
1. Adult Mode..................................................................................................................120
2. Neonate Mode ............................................................................................................ 122
3. Pediatric Mode ...........................................................................................................124
SPOT MODE....................................................................................126
1. General Operation......................................................................127
1.1 Function and key .....................................................................................................127
Operation Key ...............................................................................................................127
1.2 Screen Generating Display Mode .......................................................................... 128
1.3 Standard Menu Operation....................................................................................... 130
Menu Select...................................................................................................................132
Menu Icon Composition................................................................................................132
Numeric Value Window.................................................................................................133
Select Menu Using by Touch wheel Key ......................................................................133
Select Arrow Item Menu................................................................................................133
Letter Arrangement Menu.............................................................................................134
List selective menu........................................................................................................135
Operation Menu.............................................................................................................135
2. PATIENT/DATA MANAGEMENT..................................................136
2.1 Outline.......................................................................................................................137
2.2 Admit .........................................................................................................................137
2.3 Select Patient in Admit Information.......................................................................140
2.4 Alarm Outline ...........................................................................................................141
Alarm for the Product ....................................................................................................141

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Alarm ICON...................................................................................................................142
2.5 Alarm Setup.............................................................................................................. 143
2.6 Alarm Limit ...............................................................................................................143
2.7 Alarm Volume ........................................................................................................... 144
2.8 Alarm Level............................................................................................................... 144
2.9 Nurse Call .................................................................................................................145
2.10 Alarm Sound...........................................................................................................145
3. SAVE RECORD...........................................................................146
3.1 Outline.......................................................................................................................147
3.2 Adjust to Record Mode ........................................................................................... 147
3.3 Measure with Monitor Mode ...................................................................................147
3.4 Measure with Spot Mode......................................................................................... 148
3.5 Save...........................................................................................................................149
3.6 Exit from Saving Mode............................................................................................149
4. SAVED DATA MANAGEMENT ....................................................150
4.1 Record List View ......................................................................................................151
4.2 Exit from Record List .............................................................................................. 151
4.3 View Specified Patient’s Record List.....................................................................153
4.4 View All Patients’ Record List ................................................................................ 154
4.5 Adjust Record........................................................................................................... 154
4.6 Delete a Record........................................................................................................157
4.7 Delete a Patient’s Record........................................................................................158
4.8 Delete All Patients’ Record .....................................................................................159
5. SETUP.........................................................................................160
5.1 SETUP.......................................................................................................................161
5.2. DISPLAY................................................................................................................... 161
5.3 SAVE MODE .............................................................................................................163

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5.4 USER SERVICE........................................................................................................164
5.5 SYSTEM.................................................................................................................... 168
5.6 KEY SOUND.............................................................................................................. 168
6. NIBP ............................................................................................170
6.1 Outline.......................................................................................................................171
6.2 NIBP Data Window...................................................................................................173
6.3 NIBP Data Setup....................................................................................................... 174
ALARM LIMIT................................................................................................................174
CUFF SIZE....................................................................................................................175
UNIT SELECT...............................................................................................................175
INFLATION....................................................................................................................176
INTERVAL.....................................................................................................................176
6.4 TROUBLESHOOTING..............................................................................................177
NIBP Status Messages .................................................................................................177
Erroneous NIBP measurement.....................................................................................178
7. SpO2............................................................................................179
7.1 Outline.......................................................................................................................180
SpO2 Connector Location and Measuring Cable.........................................................180
7.2 SpO2 Data Window..................................................................................................181
7.3 SpO2Data Setup ......................................................................................................182
ALARM LIMIT................................................................................................................182
SWEEP SPEED............................................................................................................183
RATE VOLUME.............................................................................................................183
7.4 TROUBLE SHOOTING............................................................................................. 184
PROBE OFF Condition.................................................................................................184
SPO2 Messages ...........................................................................................................184
8. TEMPERATURE ..........................................................................185
8.1 Outline.......................................................................................................................186
8.2 Temperature Data Window .....................................................................................187
8.3 Temperature Data Setup.........................................................................................188

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ALARM LIMIT................................................................................................................188
TEMP MODE.................................................................................................................189
PROBE SITE (Measurement Position).........................................................................190
UNIT SELECT...............................................................................................................191
8.4 TROUBLESHOOTING..............................................................................................191
Check list.......................................................................................................................191
TEMP Message.............................................................................................................191
9. DEFAULT SETTING VALUE........................................................192
1. Adult Mode..................................................................................................................192
2. Neonate Mode ............................................................................................................ 194
3. Pediatric Mode ...........................................................................................................196
10. SPECIFICATION........................................................................198
Ease of use....................................................................................................................199
Additional Function........................................................................................................199
Monitor Environmental Specifications...........................................................................199
Power.............................................................................................................................199
Monitor Performance Specifications.............................................................................199
Graphical and Tabular Trends ......................................................................................200
SpO2capacity................................................................................................................200
NIBP capacity................................................................................................................200
Temperature Unit Performance Specifications.............................................................201
EtCO2 Module Performance Specifications.................................................................201
Accessories Included: ...................................................................................................201
Option............................................................................................................................201
Appendix A...................................................................................202
Electromagnetic Emissions and Immunity ...................................202
Abbreviations and Symbols ..........................................................207
PRODUCT WARRANTY ..................................................................210

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Note
The information in this manual only applies to BM1 patient monitor software version 1.034 .
Due to continuing product innovation, specifications in this manual are subject to change
without notice.

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B A S I C
1.1 CE Standard Information
1.2 Read before Use
Warranty Period
Warning, Caution, Note
General Precaution on Environment
General Precaution on Electric Safety
Equipment Connection, Maintenance & Washing Equipment Connection
1.3 Product Components
Product Outline
Principal Characteristics of Product
Product Configuration and Product Options
Product Body Configuration
1.4 Function and Key
External Function
Operation Key
1.5 Standard Power Supply Application
1.6 Battery Power Supply Application
1.7 General Menu Operation
Screen Composition
Menu Selection
Menu Composition

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1.1 CE Standard Information
Electromechanical safety standards met:
Information supplied by the manufacturer of medical devices
1. EN 60601-1:1990+A1:1993+A2:1995+A13:1996 (IEC 60601-1:1988+A1:1991+A2:1995)
Medical electrical equipment Part1: General requirements for safety
2. EN 60601-1-2:2001 + A1:2006 (IEC 60601-1-2:2001+A1:2004)
Electromagnetic Compatibility Requirement and tests
3. EN 55011:2007+A2:2007 Group 1 Class B(CISPR11)
Limits and methods of measurement of radio disturbance characteristics of industrial, scientific
and medical (ISM) radio-frequency equipment
4. IEC 60601-1-4:1996+A1:1999
Part 1-4 General requirements for safety Collateral standard: Programmable electrical medical
system
5. IEC 60601-1-6:2006
Part 1-6 General requirements for safety Collateral standard: Usability
6. IEC 60601-1-8:2006
Part 1-8 General requirements for safety Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
7. EN 60601-2-30:2000 (IEC 60601-2-30:1999)
Part 2-30: Particular requirements for the safety, including essential performance of automatic
cycling non-invasive blood pressure monitoring equipment
8. EN 60601-2-49:2001 (IEC 60601-2-49:2001)
Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment.
9. EN 12470-4:2000+A1:2009 : Performance test for Temperature
Clinical thermometers - Part 4: Performance of electrical thermometers for continuous
measurement

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10. EN 1060-1:1995+A2:2009, EN 1060-3:1997+A2:2009: Performance test for NIBP
Non-invasive sphygmomanometers- Part 1: General requirements, Part 3: Supplementary
requirements for electro-mechanical blood pressure measuring systems
11. EN ISO 14971:2012
Medical devices - Application of risk management to medical devices
12. EN ISO 9919:2009
Particular requirements for the basic safety and essential performance of pulse oximeter
equipments for medical use.
13. EN ISO 21647:2009 : EtCO2 test
Medical electrical equipment -- Particular requirements for the basic safety and essential
performance of respiratory gas monitors
14. EN ISO 15223-1
Symbols for use in the labeling of medical devices
15. EN 1041:2008

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1.2 Read before Use
BIONET services are always available to you.
The following are addresses and phone numbers for information, services, and product supplies.
How to Contact Us
Product Supply
Information
Bionet Ltd.
Address :
#1101 11F E&C Venture Dream Tower3 38-21, Digital-Ro 31-Gil,
Guro-Gu, Seoul , REPUBLIC OF KOREA 152-719
Overseas sales dept.
Tel:[phone]
Fax : [phone]
E-mail : [e-mail]
URL : http:// www.ebionet.com
※In the event of malfunction or failure, contact us along with the model name, serial number, and
product name of the equipment.
※If you need the supply circuit diagram, component list, description and calibration
instruction etc. you can contact us and we will provide you with it.

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Warranty Period
This product is manufactured and passed through strict quality control and through
inspection.
Compensation standard concerning repair, replacement, refund of the product complies
with “Consumer’s protection law” noticed by Economic Planning Dept.
We provide a 1-year warranty period.
We will repair or replace any part of the BM1 found to be defective in usual operating
circumstance for free to you.
This warranty does not apply to any defect caused by improper use, misuse or abuse.

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Warning, Caution, Note
For special emphasis on agreement, terms are defined as listed below in user’s manual. Users
should operate the equipment according to all the warnings and cautions.
Warning
To inform that it may cause serious injury or death to the patient, property damage, material
losses against the “warning” sign
Caution
To inform that it may cause no harm in life but lead to injury against the “caution” sign
Note
To inform that it is not dangerous but important “note” sign for proper installation, operation, and
maintenance of the equipment.

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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 moisture.
Do not touch the equipment
with wet hands.
Avoid exposure to direct
sunlight
Avoid placing in an area
where there is a high variation
of temperature.
Operating temperature
ranges from 10(C to
40(C. Operating humidity
ranges from 30% to 85%.
Avoid using or storing 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 excessive
shock or vibration.
Avoid placing in an area where
chemicals are
stored or where there is danger
of gas leakage.
Avoid inserting dust and
especially metal
materials into the
equipment
Do not disjoint or disassemble
the equipment.
We take no responsibility for
your actions.
Keep the power off
when the equipment is
not fully installed.
Otherwise, equipment
could be damaged.

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CAUTIONS
Before Installation
Compatibility is critical to safe and effective use of this device. Please contact your local sales or
service representative prior to installation to verify equipment compatibility.
Defibrillator Precaution
Patient signal inputs labeled with the CF and BF symbols with paddles are protected against
damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the
recommended cables and lead wires.
Proper placement of defibrillator paddles in relation to the electrodes is required to ensure
successful defibrillation.
Disposables
Disposable devices are intended for single use only. They should not be reused as performance
could degrade or contamination could occur.
Disposal of your old appliance
1. When this crossed out wheeled bin symbol is attached to a product it means
the product is covered by the European Directive 2002/96/EC.
2. All electrical and electronic products should be disposed of separately from
the municipal waste stream via designated collection facilities appointed by
the government or the local authorities.
3. The correct disposal of your old appliance will help prevent potential negative
consequences for the environment and human health.
4. For more detailed information about disposal of your old appliance, please
contact your city office, waste disposal service or the shop where you
purchased the product.
Electrocute Precautions
To prevent skin burns, apply electrocute electrodes as far as possible from all other electrodes, a
distance of at least 15 cm/6 in. is recommended.
EMC
Magnetic and electrical fields are capable of interfering with the proper performance of the device.

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For this reason make sure that all external devices operated in the vicinity of the monitor comply with
the relevant EMC requirements. X-ray equipment or MRI devices are possible sources of
interference as they may emit higher levels of electromagnetic radiation.
Also, keep cellular phones and other telecommunication equipment away from the monitor.

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CAUTIONS
Instruction for Use
For continued safe use of this equipment, it is necessary that the instructions are followed. However,
instructions listed in this manual in no way supersede established medical practices concerning
patient care.
Loss of Data
Should the monitor at any time temporarily lose patient data, the potential exists that active
monitoring is not being done. Close patient observation or alternate monitoring devices should be
used until monitor function is restored.
If the monitor does not automatically resume operation within 60 seconds, power cycle the monitor
using the power on/off switch. Once monitoring is restored, you should verify correct monitoring
state and alarm function.
Maintenance
Regular preventive maintenance should be carried out annually (Technical inspections). You are
responsible for any requirements specific to your country.
MPSO
The use of a multiple portable socket outlet (MPSO) for a system will result in an enclosure leakage
current equal to the sum of all individual earth leakage currents of the system if there is an
interruption of the MPSO protective earth conductor. Do not use an additional extension cable with
the MPSO as it will increase the chance of the single protective earth conductor interruption.
Negligence
BIONET does not assume responsibility for damage to the equipment caused by improperly vented
cabinets, improper or faulty power, or insufficient wall strength to support equipment mounted on
such walls.