Bionet BM3 User manual

BM3 User’s Manual
BM3 User’s Manual
Patient Monitor
Rev. 2.4

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Table of Contents
BM3 User’s Manual ............................................................................................................... 0
Table of Contents.............................................................................................................................1
1. BASIC................................................................................................................................11
1.1 CE Standard Information.......................................................................................................12
1.2 Read before Use.......................................................................................................................13
How to Contact Us......................................................................................................13
Warranty Period..........................................................................................................14
Warning, Caution, Note...............................................................................................15
General Precaution on Environment ...........................................................................16
General Precaution on Electric Safety.........................................................................20
Manufacturer’s declaration - electromagnetic emission ................................................ 21
Cleaning Applied Parts................................................................................................28
1.3 Product Components...............................................................................................................30
Product Outline...........................................................................................................30
Principal Characters of Product...................................................................................30
Product Configuration .................................................................................................31
Option Product............................................................................................................31
Product Body Configuration ........................................................................................32
Accessories ................................................................................................................34
Equipment Sign...........................................................................................................35
1.4 Function and Key ....................................................................................................................38
External Function........................................................................................................38
Operation Key.............................................................................................................38
1.5 Standard Power Supply Application .....................................................................................40
DC Power ...................................................................................................................40
1.6 Battery Power Supply Application ........................................................................................41
Operation....................................................................................................................41
The Impact of Lithium-Ion Battery Technology on the Battery.....................................43
Conditioning Guideline................................................................................................43
Storage Guideline.......................................................................................................43

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How to Recycle the Battery.........................................................................................43
To insert and remove the battery pack........................................................................44
1.7 DISPLAY MODE ( MONITOR OR SPOT )........................................................................45
MONITORING MODE........................................................................................................ 46
1. General Operation............................................................................................................ 47
1.1 General Manu Operation........................................................................................................47
Screen Composition....................................................................................................47
Menu Selection...........................................................................................................48
Menu Composition......................................................................................................48
2. PATIENT/DATA MANAGEMENT ................................................................................. 52
2.1 ADMIT.....................................................................................................................................53
ADMIT TYPE ..............................................................................................................53
CHANGE ADMIT INFO...............................................................................................54
DISCHARGE ( Discharge Patient ) .............................................................................54
ADMIT( Admit patient )................................................................................................55
HEIGHT......................................................................................................................55
WEIGHT .....................................................................................................................56
DEFAULT SETTING...................................................................................................56
2.2 ALARM....................................................................................................................................57
ALL LIMITS.................................................................................................................59
ALARM PRINT............................................................................................................59
ALARM VOLUME .......................................................................................................60
ALARM LEVEL ...........................................................................................................60
PARAMETER LEVEL..................................................................................................60
ARRHYTH LEVEL ......................................................................................................61
ALARM REVIEW ........................................................................................................62
ALARM LIST...............................................................................................................62
SAVE CONDITION .....................................................................................................64
NURSE CALL .............................................................................................................64
3. SETUP.............................................................................................................................. 66
3.1 SETUP......................................................................................................................................67
DISPLAY.....................................................................................................................67

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SET PARA..................................................................................................................68
WAVE SELECT ..........................................................................................................68
SET DATE & TIME......................................................................................................69
SET TIME ...................................................................................................................69
SET DATE..................................................................................................................70
HR SOURCE ..............................................................................................................70
SWEEP SPEED..........................................................................................................71
KEY SOUND...............................................................................................................71
DEMO.........................................................................................................................71
USER SERVICE.........................................................................................................72
SET UNIT NAME ........................................................................................................72
SET BED NUMBER....................................................................................................73
AC FILTER .................................................................................................................73
SYSTEM.....................................................................................................................74
W-LAN........................................................................................................................74
DISPLAY MODE ( MONITOR or SPOT ) ....................................................................74
MAKER SERVICE ......................................................................................................75
Freezing and Unfreezing.............................................................................................75
4. TREND ............................................................................................................................. 76
4.1 TREND.....................................................................................................................................77
GRAPHIC TREND ......................................................................................................78
TIME PERIOD.............................................................................................................79
TABULAR TREND......................................................................................................80
TIME INTERVAL.........................................................................................................81
TREND WINDOW SETUP..........................................................................................81
TIME PERIOD.............................................................................................................82
SET TREND ...............................................................................................................83
TREND PRINT............................................................................................................83
5. ECG................................................................................................................................... 84
5.1 Outline......................................................................................................................................85
Colors and Standards of Cables..................................................................................85
Position of ECG Connector and Measuring Cable.......................................................85
Attaching Electrodes to the Patient .............................................................................86
Choosing an ECG lead for Arrhythmia Monitoring.......................................................87

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Information on the ECG waveform..............................................................................87
5-Leadwire Electrode Placement.................................................................................88
3-Leadwire Electrode Placement.................................................................................88
Electrode Placement for Neonates..............................................................................89
5.2 ECG Data Window..................................................................................................................90
5.3 ECG Setup................................................................................................................................93
LEAD SELECT............................................................................................................93
ALARM LIMIT .............................................................................................................94
ALARM LEVEL ...........................................................................................................95
ALARM SOUND..........................................................................................................96
QRS VOLUME............................................................................................................97
DISPLAY.....................................................................................................................97
ECG SWEEP SPEED.................................................................................................98
ECG SIZE...................................................................................................................98
HR SOURCE ..............................................................................................................99
ANALYSIS SETTING..................................................................................................99
6. SpO2.................................................................................................................................110
6.1 Outline....................................................................................................................................111
SpO2 Connector Location and Measuring Cable ......................................................111
6.2 SpO2 Data Window...............................................................................................................112
Signal and Data Validity............................................................................................113
6.3 SpO2Setup .............................................................................................................................115
RATE VOLUME ........................................................................................................115
ALARM .....................................................................................................................116
ALARM LIMIT ...........................................................................................................116
ALARM LEVEL .........................................................................................................117
ALARM SOUND........................................................................................................118
Probe Off Condition...................................................................................................118
SPO2 Messages.......................................................................................................118
7. RESPIRATION .............................................................................................................. 120
7.1 Outline....................................................................................................................................121
7.2 Respiration Data Window ....................................................................................................122

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7.3 Respiration Setup ..................................................................................................................122
RESPIRATION SPEED.............................................................................................123
RESPIRATION SIZE.................................................................................................123
APNEA DETECT ......................................................................................................124
ALARM .....................................................................................................................124
ALARM LIMIT ...........................................................................................................125
ALARM LEVEL .........................................................................................................126
ALARM SOUND........................................................................................................126
8. NIBP ............................................................................................................................... 127
8.1 Outline....................................................................................................................................128
8.2 NIBP Data Window...............................................................................................................130
8.3 NIBP Setup.............................................................................................................................131
ALARM .....................................................................................................................131
ALARM LIMIT ...........................................................................................................132
ALARM LEVEL .........................................................................................................133
ALARM SOUND........................................................................................................133
NIBP STAT...............................................................................................................134
CUFF SIZE...............................................................................................................134
UNIT SELECT...........................................................................................................135
INTERVAL................................................................................................................135
INFLATION SET.......................................................................................................136
NIBP Status Messages.............................................................................................137
Erroneous NIBP measurement .................................................................................137
9. TEMPERATURE ........................................................................................................... 138
9.1 Outline....................................................................................................................................139
9.2 Temperature Data Window..................................................................................................140
9.3 Temperature Setup................................................................................................................141
ALARM .....................................................................................................................141
ALARM LIMIT ...........................................................................................................142
ALARM LEVEL .........................................................................................................143
ALARM SOUND........................................................................................................143
UNIT SELECT...........................................................................................................144
Check list..................................................................................................................144

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TEMP Message ........................................................................................................144
10. PRINT........................................................................................................................... 145
10.1 Print......................................................................................................................................146
Printer and Heat Sensitivity Paper.............................................................................146
Function and Setup Menu.........................................................................................147
10.2 Paper Change.......................................................................................................................150
11. MESSAGE LIST........................................................................................................... 151
12. DEFAULT SETTING VALUE..................................................................................... 152
1. Adult-ICU Mode......................................................................................................................152
2. Neonate-ICU Mode..................................................................................................................154
3. Pediatric-ICU Mode................................................................................................................156
SPOT MODE...................................................................................................................... 158
1. General Operation.......................................................................................................... 159
1.1 Function and key ...................................................................................................................159
Operation Keys.........................................................................................................159
1.2 Screen Generating Power Mode...........................................................................................160
1.3 Standard Menu Operation....................................................................................................163
Menu Select..............................................................................................................165
Menu Icon Composition ............................................................................................165
Numeric Value Window.............................................................................................166
Select Menu Using by Trim Knob Key.......................................................................166
Select Arrow Item Menu............................................................................................166
Letter Arrangement Menu .........................................................................................167
List selective menu ...................................................................................................168
Operation Menu........................................................................................................168
2. PATIENT/DATA MANAGEMENT ............................................................................... 169
2.1 Outline....................................................................................................................................170
2.2 Admit Type.............................................................................................................................170
2.3 Select Patient in Admit Information....................................................................................171

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2.4 Alarm Outline........................................................................................................................173
2.5 Alarm Setup ...........................................................................................................................174
2.6 Alarm Limit............................................................................................................................174
2.7 Alarm Print ............................................................................................................................175
2.8 Alarm Volume ........................................................................................................................175
2.9 Alarm Level............................................................................................................................175
2.10 Nurse Call.............................................................................................................................176
2.11 Alarm Sound........................................................................................................................177
3. SAVE RECORD ............................................................................................................. 178
3.1 Outline....................................................................................................................................179
3.2 Adjust to Record SAVE Mode..............................................................................................179
3.3 Measure with Monitor Mode................................................................................................179
3.4 Measure with MANUAL Mode ............................................................................................180
3.5 Save.........................................................................................................................................180
3.6 Exit from Saving Mode .........................................................................................................181
4. SAVED DATAMANAGEMENT................................................................................... 182
4.1 Record List View....................................................................................................................183
4.2 Exit from Record List............................................................................................................183
4.3 View Specified Patients Record List ....................................................................................185
4.4 View All Patients Record List...............................................................................................185
4.5 Adjust Record ........................................................................................................................186
4.6 Delete a Record......................................................................................................................187
4.7 Delete a Patients Record.......................................................................................................188
4.8 DeleteAll Patients Record ....................................................................................................188
5. SETUP............................................................................................................................ 189
5.1 SETUP....................................................................................................................................190
5.2. DISPLAY ..............................................................................................................................190

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5.3 SAVE MODE.........................................................................................................................191
5.4 USER SERVICE....................................................................................................................192
5.5 SYSTEM.................................................................................................................................192
5.6 KEY SOUND..........................................................................................................................193
5.7 MAKER SERVICE...............................................................................................................193
6. NIBP ............................................................................................................................... 194
6.1 Outline....................................................................................................................................195
6.2 NIBP Data Window...............................................................................................................196
6.3 NIBP Setup.............................................................................................................................197
ALARM LIMIT ...........................................................................................................197
CUFF SIZE...............................................................................................................198
NIBP STAT...............................................................................................................198
INFLATION SET.......................................................................................................198
UNIT SELECT...........................................................................................................198
INTERVAL................................................................................................................199
NIBP Status Messages.............................................................................................200
Erroneous NIBP measurement .................................................................................200
7. SpO2................................................................................................................................ 201
7.1 Outline....................................................................................................................................202
7.2 SpO2 Data Window...............................................................................................................203
7.3 SpO2Setup .............................................................................................................................204
ALARM LIMIT ...........................................................................................................204
SWEEP SPEED........................................................................................................205
RATE VOLUME ........................................................................................................205
ALARM LEVEL .........................................................................................................205
PROBE OFF Condition.............................................................................................206
SPO2 Messages.......................................................................................................206
8. TEMPERATURE ........................................................................................................... 207
8.1 Outline....................................................................................................................................208
8.2 Temperature Data Window..................................................................................................209

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8.3 Temperature Setup................................................................................................................210
ALARM LIMIT ...........................................................................................................210
UNIT SELECT...........................................................................................................210
PROBE SITE (Measurement Position)......................................................................211
Check list..................................................................................................................211
TEMP Message ........................................................................................................211
9. PRINT............................................................................................................................. 212
9.1 Print........................................................................................................................................213
Print and Heat Sensitivity Paper................................................................................213
Function and Setup Menu.........................................................................................214
9.2 Paper Change.........................................................................................................................216
10. TROUBLE SHOOTING .............................................................................................. 217
1. Noise in ECG............................................................................................................................217
2. SpO2 malfunction....................................................................................................................218
3. Temp malfunction ...................................................................................................................218
4. NIBP malfunction....................................................................................................................219
5. Abnormality in NIBP measurements.....................................................................................219
6. Failure in battery recharge.....................................................................................................220
7. Power failure............................................................................................................................221
8. Periodic noises..........................................................................................................................222
9. Print failure..............................................................................................................................223
SPECIFICATION.............................................................................................................. 224
Ease of use...............................................................................................................225
Additional Function ...................................................................................................225
Monitor Environmental Specifications .......................................................................225
Power .......................................................................................................................225
Monitor Performance Specifications..........................................................................225
Graphical and Tabular Trends...................................................................................226
ECG capacity............................................................................................................226
SpO2capacity...........................................................................................................226
Respiration Performance Specifications....................................................................227

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NIBP capacity ...........................................................................................................227
Temperature Unit Performance Specifications..........................................................227
Accessories Included:...............................................................................................227
Option.......................................................................................................................227
Abbreviations and Symbols................................................................................................ 228
PRODUCT WARRANTY ................................................................................................... 232

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1. BASIC
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 Option Product
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:
- EN 60601-1: 1990 + A1:1993 + A2: 1995 Medical Electrical Equipment, Part 1, General
Requirements for Safety.
- IEC/EN 60601-1-2 :2001 Electromagnetic compatibility -Requirements and tests.
- EN 1060-1:1995 Non-invasive sphygmomanometers - Part 1: General requirements
- EN 1060-3:1997 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for
electro-mechanical blood pressure measuring systems
- EN ISO 9919:2005 Medical electrical equipment - Particular requirements for the basic safety and
essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
- EN 60601-2-27:2006 Medical electrical equipment - Part 2-27: Particular requirements for the
safety, including essential performance, of electrocardiographic monitoring equipment
- EN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the
safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring
equipment
- EN 12470-4:2000 Clinical thermometers - Part 4: Performance of electrical thermometers for
continuous measurement
- EN 60601-2-49:2001 Medical electrical equipment - Part 2-49: Particular requirements for the
safety of multifunction patient monitoring equipment

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1.2 Read before Use
BIONET services are always available to you.
The followings are address and phone number for contacting information, services, and product
supplies.
How to Contact Us
Product Supply
Information
Bionet Co.,Ltd.
#1101 11F E&C Venture Dream Tower3 38-21, Digital-Ro, 31-Gil,
Guro-Gu, Seoul , REPUBLIC OF KOREA (ZIP 152-050)
Overseas sales dept.
Tel:++82-2-6300-6418
Fax : ++82-2-6300-6454
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 we will provide you with it.
The information in this manual only applies to BM3 patient monitor software version 1.10 .
Due to continuing product innovation, specifications in this manual are subject to change
without notice.

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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 Korea Fair Trade Commission.
We provide a 1-year warranty period.(Two years in Europe)
We will repair or replace any part of the BM3 found to be defective in usual operating
circumstance for free to you.
This warranty does not apply to any defect caused by improper abuse, misuse or exposure to
poor management.

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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 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.
Operating temperature
ranges from 10(C to
40(C. Operating humidity
ranges from 30% to 85%.
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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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 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 source of interference
as they may emit higher levels of electromagnetic radiation.
Also, keep cellular phones to other telecommunication equipment away from the monitor.
CAUTIONS
Instruction for Use
For continued safe use of this equipment, it is necessary that the instructions are followed. However,
instructions listed in this 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.

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NOTES
Power Requirements
Before connecting the device to the power line, check that the voltage and frequency. Ratings of the
power line are the same as those indicated on the unit’s label. If this is not the case, do not connect
the system to the power line until you adjust the unit to match the power source.
In U.S.A, if the installation of this equipment will use 240V rather than 120V, the source must
be a center-tapped, 240V, single-phase circuit.
Restricted Sale
U.S.A federal law restricts this device to sale by or on the order of a physician.
Supervised Use
This equipment is intended for use under the direct supervision of a licensed health care practitioner.
Ventilation Requirements
Set up the device in a location which affords sufficient ventilation. The ventilation openings of the
device must not be obstructed. The ambient conditions specified in the technical specifications must
be ensured at all times.
·Put the monitor in a location where you can easily see the screen and access the operating controls.
·This product is protected against the effects of cardiac defibrillator discharges to ensure proper
recovery, as required by test standards. (the screen may blank during a defibrillator discharge but
recovers within second as required by test standards.)
Reference Literature
Medical Device Directive 93/42/EEC
EN 60601-1/1990 +A1: 1993 +A2 : 1995 : Medical electrical equipment.
General requirements for safety
EN 60601-1-1/9. 1994 +A1 12.95: General requirements for safety.