Gima BM5 User manual

BM5 User Manual
Patient Monitor
Rev. 3.0
Rev. 3.0
Table of Contents
BM5 (CS, CX) User Manual.................................................................................................. 0
Table of Contents.............................................................................................................................1
1. BASIC................................................................................................................................. 8
1.1 CE Standard Information.........................................................................................................9
1.2 Read before Use.......................................................................................................................10
How to Contact Us .....................................................................................................................................10
Warranty Period..........................................................................................................................................11
Warning, Caution, Note..............................................................................................................................12
General Precaution on Environment...........................................................................................................13
General Precaution on Electric Safety........................................................................................................18
Manufacturer’s declaration - electromagnetic emission ................................................19
Cleaning Applied Parts...............................................................................................................................27
1.3 Product Components............................................................................................................... 29
Product Outline...........................................................................................................................................29
Principal Characters of Product..................................................................................................................29
Product Configuration ................................................................................................................................30
Option Product............................................................................................................................................30
Accessories.................................................................................................................................................33
Equipment Sign ..........................................................................................................................................34
1.4 Function and Key ....................................................................................................................37
External Function .......................................................................................................................................37
Operation Key ............................................................................................................................................37
1.5 Standard Power Supply Application.....................................................................................39
DC Power ...................................................................................................................................................39
1.6 Battery Power Supply Application ........................................................................................40
Operation ....................................................................................................................................................40
The Impact of Lithium-Ion Battery Technology on the Battery.................................................................42
Conditioning Guideline ..............................................................................................................................42
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Storage Guideline .......................................................................................................................................42
How to Recycle the Battery........................................................................................................................42
1.7 General Manu Operation........................................................................................................44
Screen Composition....................................................................................................................................44
Menu Selection...........................................................................................................................................45
Menu Composition .....................................................................................................................................45
2. PATIENT/DATA MANAGEMENT ................................................................................. 48
2.1 ADMIT.....................................................................................................................................50
ADMIT TYPE............................................................................................................................................50
CHANGE ADMIT INFO ...........................................................................................................................50
DISCHARGE .............................................................................................................................................51
ADMIT.......................................................................................................................................................51
HEIGHT .....................................................................................................................................................52
WEIGHT ....................................................................................................................................................52
2.2 ALARM....................................................................................................................................53
Alarm for the Product.................................................................................................................................53
ALL LIMITS..............................................................................................................................................54
ALARM PRINT .........................................................................................................................................55
ALARM VOLUME....................................................................................................................................56
ALARM REVIEW .....................................................................................................................................56
ALARM LIST ............................................................................................................................................56
SAVING CONDITION..............................................................................................................................58
ECG WAVE SELECT (ALARM LIST ECG LEAD SELECT) ................................................................58
ARRHYTH LEVEL ...................................................................................................................................58
NURSE CALL............................................................................................................................................59
3. SETUP.............................................................................................................................. 60
3.1 SETUP......................................................................................................................................61
DISPLAY ...................................................................................................................................................61
SET PARA .................................................................................................................................................61
WAVE SELECT .........................................................................................................................................62
SET DATE & TIME...................................................................................................................................64
SET TIME ..................................................................................................................................................65
SET DATE..................................................................................................................................................65
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COLOR SELECT.......................................................................................................................................65
HR/PR SELECT.........................................................................................................................................66
SET SWEEP...............................................................................................................................................67
DEMO ........................................................................................................................................................67
KEY SOUND.............................................................................................................................................67
UNIT SELECT...........................................................................................................................................68
USER SERVICE ........................................................................................................................................69
SET UNIT NAME......................................................................................................................................69
SET BED NUMBER..................................................................................................................................69
AC FILTER................................................................................................................................................70
W-LAN.......................................................................................................................................................70
SYSTEM ....................................................................................................................................................70
MAKER SERVICE....................................................................................................................................71
FREEZE MENU ........................................................................................................................................71
4. TREND .............................................................................................................................72
4.1 TREND.....................................................................................................................................73
GRAPHIC TREND ....................................................................................................................................74
TIME PERIOD...........................................................................................................................................75
TABULAR TREND...................................................................................................................................76
TIME INTERVAL .....................................................................................................................................77
TREND WINDOW SETUP .......................................................................................................................77
TIME PERIOD...........................................................................................................................................78
SET TREND PARA...................................................................................................................................79
TREND PRINT ..........................................................................................................................................79
5. ECG................................................................................................................................... 80
5.1 Introduction.............................................................................................................................81
Colors and Standards of Cables ..................................................................................................................81
Position of ECG Connector and Measuring Cable .....................................................................................82
Attaching Electrodes to the Patient.............................................................................................................82
Choosing an ECG lead for Arrhythmia Monitoring ...................................................................................83
Information on the ECG waveform............................................................................................................84
10 Position of 10-Lead ...............................................................................................................................84
5 Position of 5-Lead ...................................................................................................................................84
Position of 3-Lead Wrier Electrode ............................................................................................................85
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How to Attach the NEONATE Electrode ...................................................................................................85
5.2 ECG Data Window..................................................................................................................86
5.3 ECG Data Setup ...................................................................................................................... 89
QRS VOLUME ..........................................................................................................................................91
DISPLAY ...................................................................................................................................................91
ECG SWEEP SPEED.................................................................................................................................91
ECG SIZE...................................................................................................................................................92
VIEW ECG.................................................................................................................................................92
ANALYSIS SETTING...............................................................................................................................92
12 CH ECG ANALYSIS............................................................................................................................99
6. SpO2.................................................................................................................................111
6.1 Outline....................................................................................................................................112
SpO2 Connector Location and Measuring Cable .....................................................................................112
6.2 SpO2 Data Window...............................................................................................................113
Signal and Data Validity...........................................................................................................................114
6.3 SpO2 Data Setup....................................................................................................................116
RATE VOLUME......................................................................................................................................116
ALARM....................................................................................................................................................116
LEAD FAULT Condition.........................................................................................................................118
SPO2 Messages ........................................................................................................................................118
7. RESPIRATION ...............................................................................................................119
7.1 Outline....................................................................................................................................120
7.2 Respiration Data Window ....................................................................................................122
7.3 Respiration Data Setup.........................................................................................................123
RESPIRATION SPEED...........................................................................................................................123
RESPIRATION ........................................................................................................................................123
APNEA DETECT ....................................................................................................................................124
LEAD SELECT........................................................................................................................................124
ALARM....................................................................................................................................................124
8. NIBP ...............................................................................................................................126
8.1 Outline....................................................................................................................................127
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8.2 NIBP Data Window...............................................................................................................129
8.3 NIBP Data Setup ...................................................................................................................130
ALARM....................................................................................................................................................130
CUFF SIZE...............................................................................................................................................131
UNIT SELECT.........................................................................................................................................131
INTERVAL..............................................................................................................................................132
9. IBP.................................................................................................................................. 134
9.1 Description.............................................................................................................................135
9.2 IBP Data Window..................................................................................................................138
9.3 IBP Data Setting....................................................................................................................139
10. EtCO2............................................................................................................................ 147
10.1 Introduction.........................................................................................................................148
10.2 EtCO2 Parameter Window.................................................................................................154
10.3 EtCO2 Parameter Setting Menu........................................................................................155
EtCO2 SWEEP SPEED............................................................................................................................156
APNEA DETECT ....................................................................................................................................159
10.4 TROUBLESHOOTING......................................................................................................162
11. TEMPERATURE.......................................................................................................... 163
11.1 Outline..................................................................................................................................164
11.2 Temperature Data Window................................................................................................165
11.3 Temperature Data Setup ....................................................................................................166
ALARM....................................................................................................................................................166
UNIT SELECT.........................................................................................................................................167
12. PRINT........................................................................................................................... 168
12.1 Print......................................................................................................................................169
Printer and Heat Sensitivity Paper............................................................................................................169
Function and Setup Menu.........................................................................................................................170
PRINTER TIME.......................................................................................................................................171
PRINTER KEY .....................................................................................................................................172
Thermal Paper Storage...............................................................................................................173
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13. MESSAGE LIST ..........................................................................................................175
14. DEFAULT SETTING VALUE..................................................................................... 176
1. Adult-ICU Mode......................................................................................................................176
Alarm level ...............................................................................................................................................176
Parameter Limits ......................................................................................................................................177
Display......................................................................................................................................................178
2. Neonate-ICU Mode..................................................................................................................179
Alarm level ...............................................................................................................................................179
Parameter Limits ......................................................................................................................................180
Display......................................................................................................................................................181
3. Pediatric-ICU Mode................................................................................................................182
Alarm level ...............................................................................................................................................182
Parameter Limits ......................................................................................................................................183
Display......................................................................................................................................................184
15. TROUBLE SHOOTING .............................................................................................. 185
1. Noise in ECG............................................................................................................................185
2. SpO2 malfunction....................................................................................................................186
3. Temp malfunction ................................................................................................................... 186
4. NIBP malfunction....................................................................................................................187
5. Abnormality in NIBP measurements.....................................................................................187
6. Failure in battery recharge.....................................................................................................188
7. Power failure............................................................................................................................189
8. Periodic noises..........................................................................................................................190
9. Print failure..............................................................................................................................191
16. SPECIFICATION ........................................................................................................ 192
Ease of use................................................................................................................................................193
Additional Function..................................................................................................................................193
Monitor Environmental Specifications.....................................................................................................193
Power........................................................................................................................................................193
Specification.............................................................................................................................................193
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Accessories Included:...............................................................................................................................196
Option.......................................................................................................................................................196
Abbreviations and Symbols................................................................................................197
PRODUCT WARRANTY ...................................................................................................200
Without prior notice, the specification and function are subject to change to enhance the
product in this manual.
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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 + A13:1996 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 60601-2-34:2000 Medical electrical equipment - Part 2: Particular requirements for the safety,
including essential performance, of invasive blood pressure monitoring equipment
- EN 12470-4:2001 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
GIMA services are always available to you.
The followings are address and phone number for contacting information, services, and product
supplies.
How to Contact Us
 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.
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Warranty Period
y This product is manufactured and passed through strict quality control and through
inspection.
y Compensation standard concerning repair, replacement, refund of the product complies
with “Consumer’s protection law” noticed by Economic Planning Dept.
y Warranty period is 1 year.(Two year in Europe).
y We will repair or replace any part of the BM5 (CS, CX) found to be defective in usual
operating circumstance for free to you.
y 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 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
To inform that it may cause no harm in life but lead to injury against the “caution” sign
To inform that it is not dangerous but important “note” sign for proper installation, operation, and
maintenance of the equipment.
Caution
Note
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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 placing in an area
where there is a high variation
of temperature.
Operating temperature
ranges from 10(C to
Avoid exposure to direct
sunlight
Avoid in the vicinity of
Electric heater
40(C. Operating humidity
ranges from 30% to 85%.
Avoid placing in an area where
there is an excessive
humidity rise or ventilation
problem.
Avoid placing in an area where
chemicals are
stored or where there is danger
of gas leakage.
Avoid placing in an area
where there is an
excessive shock or
vibration.
Avoid being inserted
dust and especially
metal
material into the
equipment
Power off when the
Do not disjoint or disassemble
the equipment.
We take no responsibility for
it.
equipment is not fully
installed.
Otherwise, equipment
could be damaged.
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BM5 User’s Manual
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.
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EMC
Magnetic and electrical fields are capable of interfering with the proper performance of the device.
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.
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BM5 User’s Manual
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
GIMA 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.
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General Precaution on Electric Safety
Warning
BM5 OPERATION MANUAL
Check the item listed below before operating the equipment.
NOT
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 GIMA. (DC18V, 2.5A)
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.
Note
The Equipment should be placed far from generator, X-ray equipment, broadcasting equipment
or transmitting wires, so as to prevent the electrical noises from being generated during the
operation, When these devices are near the Equipment, it can produce inaccurate
measurements. For BM5 (CS, CX) 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.
Warning
Do not contacts with the patient while operate the machine It may cause serious danger to the
users. Use only the provided cable.
A warning that other cables and accessories may negatively affect EMC performance
Warning
In case the Equipment does not operate as usual or damaged, do not use on patient, and
contact to the medical equipment technician of the hospital or the equipment supply division.
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Note
BM5 (CS, CX) is classified as follows:
- BM5 (CS, CX) classifies as Class I, BF & CF concerning electric shock. It is not proper to
operate this Equipment around combustible anesthetic or dissolvent.
- Noise level is B class regarding IEC/EN 60601-1 and the subject of Nose is B level concerning
IEC/EN60601-1-2.
Equipment Connection
For measurements in or near the heart we recommend connecting the monitor to the potential
equalization system. Use the green and yellow potential equalization cable and connect it to the pin
labeled with the symbol
.
Manufacturer’s declaration - electromagnetic emission
The BM5 system is intended for use in the electromagnetic environment specified below. The
customer or the user of BM5 system should assure that it is used in such an environment
Emission test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Group 1 The BM5 system uses RF energy only for its
internal function. Therefore. Its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment
Class B
The BM5 system is suitable for use in all establi
shments other than domestic and those directly
Harmonics emission
IEC 61000-3-2
Voltage fluctuation
IEC 61000-3-3
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A
Complies
connected to the public low-voltage power sup
plies buildings used for domestic purposes.
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BM5 User’s Manual
Manufacturer’s declaration - electromagnetic immunity
The BM5 system is intended for use in the electromagnetic environment specified below.
The customer or the user of the BM5 system should assure that it is used in such an environment
Immunity test IEC 60601
Test level
Electrostatic dis
charge (ESD)
IEC 61000-4-2
Electrical fast
Transient / burs
t
IEC 61000-4-4
Surge
IEC 61000-4-5
6 kV Contact
8 kV Air
2kV for power supply lin
es 1kV for input/output li
nes
1 kV differential mode
2 kV common mode
Compliance level Electromagnetic
Environment -guidance
6 kV Contact
8 kV Air
2kV for power supply li
nes
1kV for input/output lin
es
1 kV differential mode
2 kV common mode
Floors should be wood, co
ncrete or ceramic tile. If f
loors are covered with sy
nthetic material, the relati
ve humidity should be at l
east 30 %
Mains power quality shoul
d be that of a typical com
mercial or hospital environ
ment.
Mains power quality shoul
d be that of a typical com
mercial or hospital environ
ment.
Power frequenc
y
(50/60Hz)
Magnetic field
IEC 61000-4-8
3.0 A/m 3.0 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical comm
ercial or hospital environm
ent.
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<5%
U
Voltage dips, s
hort
Interruptions an
d
Voltage variatio
ns
on power suppl
y
input lines
IEC 61000-4-1
1
Note: Uт is the a.c. mains voltage prior to application of the test level.
The BM5 system is intended for use in the electromagnetic environment specified below.
)
for 0.5cycle
40%
)
for 5 cycle
70%
for 25 cycle
<5%
)
for 5 s
т (>95% dip in
U
т (60% dip in
U
т (30% dip in )
U
т (<95% dip in
<5%
U
т (>95% dip in
т)
for 0.5cycle
40%
U
т (60% dip in
)
for 5 cycle
70%
U
т (30% dip in )
for 25 cycle
<5%
U
т (<95% dip in
т )
for 5 s
Mains power quality shoul
U
d be that of a typical com
mercial or hospital environ
ment. If the user of the
BM5 system requires conti
nued operation during pow
er mains interruptions, it i
s recommended that the
BM5 system be powered fr
om an uninterruptible pow
er supply or a battery
U
The customer or the user of the BM5 system should assure that it is used in such an environment
Immunity test IEC 60601
Test level
Conducted RF
IEC 61000-4-
6
3 Vrms
150 kHz to 80 M
Hz
Compliance level Electromagnetic environment -guidance
3 Vrms
150 kHz to 80 MH
z
Portable and mobile RF communications
equipment should be used no closer to
any part of the BM5 system, including
cables, than the recommended separati
on distance calculated from the equatio
n applicable to the frequency of the tra
nsmitter.
Recommended separation distance
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Radiated RF
IEC 61000-4-
3
3 V/m
80.0 MHz to 2.5
GHz
3 V/m
80.0 MHz to 2.5 G
Hz
Recommended separation distance
Where
rating of the transmitter in watts (W)
according to the transmitter manufactur
er and
n distance in meters (m).
Field strengths from fixed RF transmitt
ers, as deter-mined by an electromagn
etic site survey,
(a) Should be less than the compliance
P
is the maximum output power
d
is the recommended separatio
level in each frequency range (b).
Interference may occur in the vicinity
of
equipment marked with the following s
ymbol:
Note 1) Uт is the A.C. mains voltage prior to application of the test level.
Note 2) At 80 MHz and 800 MHz, the higher frequency range applies.
Note 3) These guidelines may not apply in all situations. Electromagnetic propagation is affec
ted by absorption and reflection from structures, objects and people.
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a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) te
lephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcas
t cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the mea
sured field strength in the location in which the EUT is used exceeds the applicable RF comp
liance level above, the EUT should be observed to verifynormal operation. If abnormal perfor
mance is observed, additional measures may be necessary, such as re-orienting or relocating
the EUT.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V
/ m.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment
and
the BM5 system.
The BM5 system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of the BM5 system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the BM5 system as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum output
power (W) of transmitter
Separation distance (m) according to frequency of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.70 3.70 7.37
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended separa
tion distance (d) in meters (m) can be estimated using the equation applicable to the frequenc
y of the transmitter, where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer.
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Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range app
lies
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affec
ted by absorption and reflection from structures, objects, and people.
Immunity and Compliance Level
Immunity test IEC 60601 Test Level Actual Immunity Level Compliance Level
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms, 150 kHz to 80
MHz
3 V/m, 80 MHz to 2.5 GHz 3 V/m, 80 MHz to 2.5 GHz 3 V/m, 80 MHz to 2.5 GHz
3 Vrms, 150 kHz to 80
MHz
3 Vrms, 150 kHz to 80
MHz
Guidance and manufacturers declaration - electromagnetic immunity
The BM5 system is intended for use in the electromagnetic environment specified below.
The customer or the user of the BM5 system should assure that it is used in such an environment
Immunity test IEC 60601
Test level
Conducted RF
IEC 61000-4-
6
3 Vrms
150 kHz to 80M
Hz
Compliance level Electromagnetic environment -guidance
3 Vrms
150 kHz to 80 M
Hz
BM5 system must be used only in a shi
elded location with a minimum RF shiel
ding effectiveness and, for each cable t
hat enters the shielded location with a
minimum RF shielding effectiveness and
, for each cable that enters the shielde
d location
Rev. 3.0 1.BASIC
24
BM5 User’s Manual
Radiated RF
IEC 61000-4-
3
Note 1) These guidelines may not apply in all situations. Electromagnetic propagation is affec
ted by absorption and reflection from structures, objects and people.
Note 2) It is essential that the actual shielding effectiveness and filter attenuation of the shie
lded location be verified to assure that they meet the minimum specification.
3 V/m
80.0 MHz to 2.5
GHz
3 V/m
80.0 MHz to 2.5
GHz
Field strengths outside the shielded loc
ation from fixed RF transmitters, as det
ermined by an electromagnetic site surv
ey, should be less than 3V/m.a
Interference may occur in the vicinity o
f equipment marked with the following
symbol:
a- Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadc
ast cannot be predicted theoretically with accuracy. To assess the electromagnetic environme
nt due to fixed RF transmitters, an electromagnetic site survey should be considered. If the
measured field strength outside the shielded location in which the EUT is used exceeds 3V/
m, the EUT should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as relocati
ng the EUT or using a shielded location with a higher RF shielding effectiveness and filter at
tenuation.
Note
For Type A Professional ME Equipment intended for use in domestic establishment instructions
for use includes a warning:
This ME equipment is intended for use by professional healthcare personnel only.
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BM5 User’s Manual
Caution
In the hospital, doctors and patients are exposed to dangerous, uncontrollable compensating
currents. These currents are due to the potential differences between connected equipment The
safety solution to the problem is accomplished with EN60601-1;1996.
Biocompatibility
When used as intended, the parts of the product described in this operator manual, including
accessories that come in contact with the patient during the intended use, fulfill the biocompatibility
requirements of the applicable standards. If you have questions about this matter, please contact
GIMA or its representatives.
Maintenance and Washing Equipment Connection
Using various methods can clean BM5 (CS, CX) and its accessories. Please follow the methods
mentioned below to avoid unnecessary damage or contamination to the Equipment.
We do not repair with free of charge regardless of warranty period if it is contaminated or damaged
with using dangerous material not designated for washing.
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BM5 User’s Manual
Cleaning Applied Parts
Cables and Leadwires
CAUTION
Do not use acetone or keytone solvents for cleaning; do not use an autoclave or steam cleaner.
Cables and leadwires can be cleaned with a warm, damp cloth and mild soap, or isopropyl alcohol
wipes. For more intensive disinfecting (near sterile) Ethylene Oxide (ETO) is acceptable but will
reduce the useful lifetime of the cable or leadwire.
CAUTION
The decision to sterilize must be made per your institution’s requirements with an awareness of
the effect on the integrity of the cable or leadwire.
Note
The Equipment needs safety inspection once a year. Please refer to user’s guide or service
manual for the examine objects.
Please check carefully both frame and sensor, after cleaning the Equipment, Do not use the
equipment that is worn out or damaged.
At least once a month, clean and wipe off the frame by using the soft cloth after wetting it with water
and alcohol. Do not use lacquer, thinner, ethylene, and oxidizer which may leads damage to the
equipment.
Make sure both cables and accessories are free of dust or contaminants, and wipe them off with soft
cloth wetted with warm water (40°), and at least once a week, clean them by using the clinical
alcohol.
Do not submerge the accessories under any liquid or detergent. Also, make sure any liquid not to
penetrate into the Equipment or probe.
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BM5 User’s Manual
Caution
Do not dispose single use probe to any hazard place, Always think about environmental
contamination.
Caution
There is back-up battery on board inside system. When users dispose this battery, Please
waste proper place for environmental protection.
Warning
Check the electrodes of batteries before changing them.
· Operate BM5 (CS, CX) with internal electric power supply when unsure of external ground
connection or installation occur.
· Remove the 1st Battery when not using equipment for a while without any damage.
For other applied parts such as temperature sensors, pulse oximetry probes, and NBP cuffs, you
must consult the manufacturer for cleaning, sterilization, or disinfecting methods.
Rev. 3.0 1.BASIC
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BM5 User’s Manual
1.3 Product Components
BM5 OPERATION MANUAL
Product Outline
BM5 (CS, CX) monitor is a product used for monitoring biological information and occurrence of a
patient. Main functions of the product include displaying information such as ECG, respiration, SpO2,
NIBP, IBP, EtCO2 and temperature on its LCD screen and monitoring parameter, and alarming. It
also prints out waves and parameters via a printer.
Principal Characters of Product
BM5 (CS, CX) is a small-size multifunctional monitoring equipment for a patient designed to an easy
usage during movement. It features devices for auto power supply (DC 10V-16V) and DC power
supply (DC 18V) as well as installing its handle to the patient’s bed. The equipment also measures
major parameters such as ECG, respiration rate, SpO2, pulse rate, NIBP, IBP, EtCO2, and
temperature, displaying them on a 10.4-inch color LCD screen. It also enables users to check waves
and parameters and other vital signs of a patient via the 58mm thermal printer and monitor the
patient by the remote-controlled alarm system. It also enables to build a central monitoring system
by linking devices used for separate patients so that one can monitor several patients at a time.
Warning
Use only the supplement accessories provided by us. Otherwise, patient and user may exposed
to danger.
Warning
BEFORE USE — Before putting the system into operation visually inspect all connecting cables
for signs of damage. Damaged cables and connectors must be replaced immediately.
Before using the system, the operator must verify that it is in correct working order and
operating condition. Periodically, and whenever the integrity of the product is in doubt, test all
functions.
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BM5 User’s Manual
Product Configuration
1. Main body of BM5(CS, CX) Monitor 1 EA
2. 5-Lead ECG Cable 1EA
3. Disposable electrodes 10 EA
4. NIBP extension tube 1EA
5. Reusable Adult NIBP Cuff 1EA
6. SpO2 sensor extension cable 1EA
7. Reusable Adult SpO
8. DC Adaptor (MW160 made in AULT Co., Ltd.) 1 EA
9. Chart Paper 2ROLL
2 Probe 1 EA
Option Product
1. Temperature probe
2. 3-Lead ECG Cable (MECA3(AHA),MECE3(IEC))
3. 10-Lead ECG Cable (MECA10(AHA),MECE10(IEC))
4. IBP kit
5. EtCO2 Module
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 GIMA
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. 3.0 1.BASIC
30
Features of Main Body
BM5 User’s Manual
Rev. 3.0 1.BASIC
31
BM5 User’s Manual
ECG CONNECTOR
NIBP CONNECTOR
SpO2 CONNECTOR
TEMPERATURE CONNECTOR
EtCO2 CONNECTOR
IBP CONNECTOR
Rev. 3.0 1.BASIC
32
Accessories
ECG Cable +
Extension Cable
SpO2 Cable +
Extension Cable
BM5 User’s Manual
NIBP Cuff+
Extension cable
Temperature
sensor (Option)
Rev. 3.0 1.BASIC
33
Equipment Sign
BM5 User’s Manual
ATTENTION :
Consult accompanying documents
TYPE CF APPLIED PART :
Insulated (floating) applied part suitable for intentional external and internal
application to the patient including direct cardiac application. "Paddles"
outside the box indicate the applied part is defibrillator proof.
Medical Standard Definition :
F-type applied part(floating/insulated) complying with the specified
requirements of IEC 60601-1/UL 2601-1/CSA 601.1
Medical Standards to provide a higher degree of protection against electric
shock tan that provided by type CF applied parts.
TYPE BF APPLIED PART :
Insulated (floating) applied part suitable for intentional external and internal
application to the patient excluding direct cardiac application. "Paddles"
outside the box indicate the applied part is defibrillator proof.
Medical Standard Definition :
F-type applied part (floating/insulated) complying with the specified
requirements of IEC 60601-1/UL 2601-1/CSA 601.1
Medical Standards to provide a higher degree of protection against electric
shock than that provided by type BF applied parts.
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BM5 User’s Manual
Ground
Printer
LAN Port
Serial Port
AUX Connector Port
DC Input Indicator
Battery Operation Indicator
DC Input Connector
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BM5 User’s Manual
NIBP
Temperature
Function
Power on
Power off
Respiration
ECG
Heart Pulse
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BM5 User’s Manual
1.4 Function and Key
External Function
The front panel of this product consists of an LCD screen and five function keys and one trim knob.
Alarm Lamp
Parameter window
Silence Alarm
Print Go/Stop
Screen
Operation Key
1. Power : Switches on and off the Power.
2. Function Key
3. Blood PressureManually completes measuring blood pressure.
NIBP Go/Stop
Funtion
Trim Knob
Power
Battery Power LED
DC Power LED
4. PrinterPrints out the waves selected from the menu until the key is pressed to stop.
5. Alarm Stop alarm sound.
First press stops the current alarm for one minute
Second press stops the all alarm for five minutes.
Third press makes the alarm back to the original setting.
6. Trim KnobThis key is used to select menu by turning it clock or anticlockwise to move cursors.
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38
BM5 User’s Manual
1.5 Standard Power Supply Application
DC Power
DC Power LED is lighted on when the DC Power is plugged into the inlet at the back of the product.
A press of power key makes the machine ready for use.
Warning
This equipment must only be connected to a supply mains with protected earth.
Rev. 3.0 1.BASIC
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BM5 User’s Manual
1.6 Battery Power Supply Application
Battery power can be supplied for enabling a portable use or a use during DC power failure.
Operation
1. Battery Power LED is lighted on when the machine is in use.
2. The DC/battery power is only sustainable for 1 hour.
3. Battery is automatically charged when the machine is connected
to
DC Power Supply. Battery LED is lighted on after blinking.
4. The charging status of the batteries is displayed with 5 green boxes, each indicating a different
charging
. ( 0% -> 25% -> 50% -> 75% -> 100%)
z Battery: LS1865L2203S1PMXZ(11.1V - 2200mA, Li-ion)
The Lithium-Ion battery is a rechargeable battery containing Lithium-Ion cells. Each battery contains
an integrated electronic fuel gauge and a safety protection circuit.
5. The discharge condition of battery is indicated with on of 5 yellow boxes, each box showing a
different level of charge available.
.
Rev. 3.0 1.BASIC
40
BM5 User’s Manual
(100% -> 75% -> 50% -> 25% -> 0%)
When remained battery is less than 25%, the battery icon box is turned to red one with blink.
The device will be turned off automatically after 5 minutes from that warning sign. In case of that
warning sign with red and blink at icon box, charge the device immediately with DC power
adaptor which is provided from GIMA.
-Battery charging time: More than 6 hours
-Continuous battery use time: Lowest 1 hour to highest 2 hours continuous use (buffering)
Warning
Check the electrodes of batteries before charging them.
6. Battery status indication: When battery is apart from equipment and out of order, it is shown by a
red `X' as shown below.
7. Automobile power supply: When an automobile power uses 12V~15V, the battery indication
disappears and the ”CAR” indication is active.
Display of automobile power
Rev. 3.0 1.BASIC
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BM5 User’s Manual
Note
Battery is not charged when the automobile power is used.
The Impact of Lithium-Ion Battery Technology on the Battery
The following are the key points you should know about Lithium-Ion battery technology:
The battery will discharge on its own, even when it is not installed in a monitor. This discharge is the
result of the Lithium-Ion cells and the bias current required for the integrated electronics.
By the nature of Lithium-Ion cells, the battery will self-discharge.
The self-discharge rate doubles for every 10°C (18°F) rise in temperature.
The capacity loss of the battery degrades significantly at higher temperatures.
As the battery ages, the full-charge capacity of the battery will degrade and be permanently lost. As
a result, the amount of charge that is stored and available for use is reduced.
Conditioning Guideline
the battery in the monitor full charged and discharged every six months and condition it using the
battery charger.
Storage Guideline
Store the battery outside of the monitor at a temperature between 20°C to 25°C (68°F to 77°F).
When the battery is stored inside a monitor that is powered by an AC power source, the battery cell
temperature increases by 15°C to 20°C (59°F to 68°F) above the room’s ambient temperature. This
reduces the life of the battery.
When the battery is stored inside a monitor that is continuously powered by an AC power source
and is not powered by battery on a regular basis, the life of the battery may be less than 12 months.
GIMA recommends that you remove the battery and store it near the monitor until it is needed for
transport.
How to Recycle the Battery
When the battery no longer holds a charge, it should be replaced. The battery is recyclables.
Remove the old battery from the monitor and follow your local recycling guidelines.
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BM5 User’s Manual
WARNING
EXPLOSION HAZARD —
DO NOT incinerate the battery or store at high temperatures. Serious injury or death could
result.
Rev. 3.0 1.BASIC
43
1.7 General Manu Operation
Screen Composition
Real Time Wave
Window
BM5 User’s Manual
Parameter
Windows
Menu Select Window
Real Time Wave WindowDisplays measured results by up to three waves.
Menu Select WindowMenus appear when they are activated..
Parameter WindowMeasured and setup data are displayed in five windows.
Rev. 3.0 1.BASIC
44
Menu Selection
BM5 User’s Manual
Turn or press the knob.
When the Trim Knob Key is turned, menus are selected in the order indicated above. The above
screen shows that the MORE menus is selected. The menus move to the right in the order of MORE
MENU ECG NIBP SpO
is jumped off.
2 RESP(EtCO2) IBP1 IBP2 TEMP. An inactivated window
Menu Composition
More Menu Window
When the additional menu is selected it will set and cancel the functions.
Rev. 3.0 1.BASIC
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BM5 User’s Manual
Numerical value sign widow
This window displays a measured parameter, function setup, and the boundary of parameter values.
Parameter
value
Breathing rate
Menu selection by using Trim Knob key
As the key is turn to the right, the menu selection moves clockwise. As the key is turn to the left, the
menu selection moves counterclockwise. The menu selection is activated when you depress Trim
Knob key.
Menu selection with arrows
Upward Movement: Turns the Trim Knob key to the left.
Downward Movement: Turns the Trim Knob key to the right.
Selection is made by pressing the Trim Knob key. One comes out of the menu after the selection.
When moving the within quadrilateral, the letter reverses, and the numeric value reflects
immediately.
MAIN
MENU
PREV
MENU
QRS VOLUME :
> OFF 60%
10% 70% 20% 80% 30% 90% 40% 100% 50%
Rev. 3.0 1.BASIC
46
BM5 User’s Manual
Word feature menu
The following figure shows the screen where the word sequence menu is activated within the word
sequence correction menu. Here, the cursor moves over the words when the Trim Knob key is
turned in the clockwise direction.
The above figure shows how the cursor moves on the screen. The cursor moves according to the
direction the Trim Knob Key is turned. Press the Trim Knob key if you want to change a letter
currently on the screen.
The above figure shows how the cursor is selected to change a letter. Right-hand turning of the Trim
Knob Key makes it possible to select in the order of 0-9,A-Z, and a blank, while left-hand turning
makes the movement in the opposite direction. Once a letter or a number is selected, the screen
comes back to the condition where the same process of selection can be made. One may move to
the menu item in the left of the screen to end the process, which is completed by pressing Trim
Knob Key. After completion, the screen comes back to the earlier picture.
Operation menu
The setup value changes without a selection when the menu is moved.
Rev. 3.0 1.BASIC
47
2. PATIENT/DATA MANAGEMENT
2.1 ADMIT
CHANGE ADMIT INFO
DISCHARGE
HEIGHT
WEIGHT
2.2 ALARM
ALL LIMITS
ALARM PRINT
ALARM VOLUME
ALARM LEVEL
ARRHYTH LEVEL
ALARM REVIEW
ALARM LIST
SAVE ALARM LEVEL
NURSE CALL
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 48
Additional setups are made foe each parameter function. One can make an overall setup for the
entire monitor system.
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 49
BM5 User’s Manual
2.1 ADMIT
CHANGE ADMIT INFO DISCHARGE HEIGHT UNIT WEIGHT UNIT
ADMIT TYPE
Set the exercise environment of equipment in discharge status.
ADU : ADULT ICU // PED: PEDIATRIC ICU // NEO : NEONATE ICU
CHANGE ADMIT INFO
Last and first name (11 letters for each), sex (male or female), date of birth, weight, height, and
patient ID (11 characters)
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 50
BM5 User’s Manual
DISCHARGE
Patient information and all numbers change to standard, and the screen displays, “ALL ALARMS
OFF ADMIT PATIENT TO ACTIVE ALARMS.”
ADMIT
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 51
HEIGHT
Unit of height is set as Cm / Inch.
BM5 User’s Manual
WEIGHT
Unit of weight is set as Kg / LBS.
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 52
BM5 User’s Manual
2.2 ALARM
Alarm is divided into two, alarm for the patient’s condition and for the product’s condition.
The patient’s alarm sounds when the diagnostic functions (ASYSTOLE, VTAC/VFIB, and VTAC) are
detected. Each alarm sound differs in order in order and volume according to the levels of HIGH,
MEDIUM, LOW and MESSAGE.
HIGH
MEDIUM
LOW
MESSAGE
250
: Waves are printed out
-5
-1
: Alarm sounds
: Number flashes
-3
250
250
250
250
: Alarm lamp flashes
Alarm for the Product
The machine gives alarm sounds for its system with a related message flashing.
LOW
-1
ALARM LIMITSThe machine enables one to see and change the limits of alarm for all parameter
functions.
ALARM PRINTwith an ON/OFF setup, the related information is printed out whenever an alarm is
given.
ALARM VOLUMEvolume of each alarm can be adjusted in 10 step.
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 53
Alarm
Text
BM5 User’s Manual
ALARM LEVELPriority of each parameter alarm can be set up.
ALARM REVIEW Shows the priority order information for all alarms of each measurement.
NURSE CALL Set the ON/OFF feature of the NURSE CALL.
It is able to see all the alarm range and change of measurement function.
ALL LIMITS
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 54
BM5 User’s Manual
ALARM PRINT
Set ON/OFF functions automatically. When the alarm is activated the corresponding information is
printed on heat sensitive paper. Alarm level upper than MEDIUM Level. But, LEAD FAULT AND
LOW BATTERY Alarm isn’t activated the alarm print when alarm is set.
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 55
BM5 User’s Manual
ALARM VOLUME
Set the alarm volume to be set at 10 grades.
ALARM REVIEW
After an alarm is triggered the alarms and data wave pattern can be reviewed. Set up for priority of
each parameter alarm.
ALARM LIST
When an alarm activates, this shows the order of the alarms.
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 56
BM5 User’s Manual
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 57
BM5 User’s Manual
SAVING CONDITION
This determines the alarm level of parameters which are saved in the alarm list, when alarm occurs.
If the higher level of alarm only occurs than the previously determined alarm level, data would be
saved in the alarm list.
ECG WAVE SELECT (ALARM LIST ECG LEAD SELECT)
This set ECG LEAD which is indicated in the saved alarm list.
ARRHYTH LEVEL
This set alarm level in arrhythmias analysis.
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 58
BM5 User’s Manual
ARRHYTH ALARM LEVEL
RETURN
ASYSTOLE
VTAC
VTAC/VFIB
BIGEMINY
ACC VENT
COUPLET
IRRGULAR
PAUSE
PVC
R ON T
TRIGEMINY
V BRADY
SHORT RUN
MESSAGE
HIGH HIGH
HIGH MESSAGE MESSAGE MESSAGE
LOW
LOW MESSAGE MESSAGE MESSAGE
MEDIUM MEDIUM
NURSE CALL
When an alarm is triggered, this activated the NURSE CALL function.
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 59
3. SETUP
3.1 SETUP
DISPLAY
DEMO
USER SERVICE
MAKER SERVICE
Rev. 3.0 3.SETUP 60
3.1 SETUP
DISPLAY : screen set menu KEY SOUND : This is the menu to set the key sound generation. USER SERVICE : This is the menu to set the connection used to interface with an external computer. DEMO: This is the menu to set the demonstration. MAKER SERVICE : This is the basic adjustment menu used to adjust the features of this product.
DISPLAY
SET PARAMeasurement function selected. WAVE SELECTSet wave pattern source at the bottom of the WINDOW with LARGE SET DATE & TIME: Set and change date and time. HR/PR SOURCESet and select HR/PR source. COLOR SELECT: Set screen display color.
SET SWEEP: Set speed of ECG, RESP WAVE DISPLAY
SET PARA
Select measurement function to use
Rev. 3.0 3.SETUP
61
BM5 User’s Manual
WAVE SEL ECT
Select waveform to display in large parameter display.
MAIN
MENU
PREV
MENU
SET
PARA
SWEEP SPEED: 25mm/s
WAVE
SELECT:
SPO2
COLOR
SELECT
SET
DATE & TIME
HR/PR
SELECT:
ECG
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62
BM5 User’s Manual
* The large parameter display at the selection of SpO2
* The large parameter display at the selection of RESP
10- JAN- 2008 12:23
BPM
150/50
JOHN
mmHg
200 80
P
%SpO2
II
X1
100/90
II X4RR
ADT
09:58
1HR
0:56
PVC (/min):- ,
00001A
ST(mm): 0.0
T1
42.0
30.0
T1
42.0
30.0
ART
S
150
70
CVP
RPM
30/10
20S
M
15
BED- 001
Rev. 3.0 3.SETUP
3
63
BM5 User’s Manual
z The large parameter display at the selection of EtCO2
SET DATE & TIME
It has sub menu to set date and time.
Rev. 3.0 3.SETUP 64
SET TIME
Set time of equipment.
BM5 User’s Manual
SET DATE
Set date of equipment
COLOR SELECT
This is the menu to set the waveform and parameter color selection.
It has ten color below table.
The color of parameter could be changed in ten colors from following table.
Rev. 3.0 3.SETUP 65
BM5 User’s Manual
HR/PR SELECT
This menu is used to set the source that detects heart and pulse rate.
The source can select among ECG and SPO2.
Rev. 3.0 3.SETUP 66
BM5 User’s Manual
SET SWEEP
Set speed of drawing wave signal pattern in this widow.
DEMO
Set ON/OFF DEMONTRATION of equipment.
KEY SOUND
This is the menu for KEY SOUND to ON/OFF.
Rev. 3.0 3.SETUP 67
BM5 User’s Manual
UNIT SELECT
This is the menu for converting the units of BM5.
The units of parameters for pressure, ST LEVEL, Temperature are able to convert.
Pressure unit selection menu
ST LEVEL unit selection menu
Temperature Unit selection menu
Rev. 3.0 3.SETUP 68
BM5 User’s Manual
USER SERVICE
The user is able to set the communication parameters, power supply filter, and patient’s age.
SET UNIT NAME
Set up for Equipment name.
SET BED NUMBER
Set up for patient bed number.
Allowable setters are from 1 to 255.
Rev. 3.0 3.SETUP 69
BM5 User’s Manual
AC FILTER
AC FILTER is function where you can set power supply frequency. This feature is required because
power supply frequency can be different from one country to another. . (The selectable frequencies
are 50Hz and 60Hz, OFF.)
W-LAN
Power supplying of W-LAN module could be adjusted with this function.
SYSTEM
System able to change and verify Equipment version information and system information
Rev. 3.0 3.SETUP 70
BM5 User’s Manual
MAKER SERVICE
Maker service is a menu is used by manufacturers.
FREEZE MENU
If you select the icon which is located in the far left in the icon menu with controlling a rotary switch,
the wave window is held and is maintained as the previous status, at the same time the parameter
windows is normally showing the current patient’s status.
Whenever selecting the FREEZE menu, the FREEZE and RELEASE are repeated by turns.
The FREEZE is released by the following two conditions.
1. 3 minutes after selecting FREEZE menu.
2. Selection of the releasing FREEZE menu.
Rev. 3.0 3.SETUP 71
4. TREND
4.1 TREND
GRAPHIC TREND
TABLE TREND
TREND WINDOW SETUP
Rev. 3.0 4.TREND 72
4.1 TREND
TREND shows saved data graphically displayed with numeric values.
Real-time data recording duration is 1 minute. Amount of saving time is for this data will be saving
for 168hours.
: Move to main screen
: Move within the tables
: Move up to other analysis function
: Move down to other analysis function
: Time period set menu
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BM5 User’s Manual
GRAPHIC TREND
Wave Data can be stored and seen according to section.
REV. 3.0 4.TREND 74
BM5 User’s Manual
TIME PERIOD
One can set up and store data and time that one can see in a screen.
REV. 3.0 4.TREND 75
BM5 User’s Manual
TABULAR TREND
One can see the stored data at the time previously set up.
REV. 3.0 4.TREND 76
TIME INTERVAL
One can store data and set up time.
10- MAY
12:09
79
0.0 0
98 80
36.7
36.9 20
127
94 83 79
0
12
0 0
JOHN
10- MAY
12:08
10- MAY- 09 12:23
II
ST(mm)
II X1
III
HR
ST
PVC NIBP- S NIBP- M NIBP- D
SPO2- %
SPO2- R
SpO2
TEMP1 TEMP2
AWRR IBP1- S IBP1- M IBP1- D
IBP1- PR
IBP2- S
II
IBP2- M
RR II
IBP2- D
IBP2- PR
EtC O2
FiCO2
1
5
0.0
ST(mm)- - .-
10- MAY
12:10
80
0.0 0
120
93 80 99 80
36.7
36.9 20
128
94 82 79
0
12
0 0
15 30 60
BM5 User’s Manual
10- MAY
12:07
80
0.0 0
119
92 83 99 80
36.8
36.9 20
128
95 82 79
0
12
0 0
80
0.0 0
98 80
36.7
36.9 20
128
94 82 79
0
12
0 0
Ver.4.00BHCDDC
MEDICU0111A
PVC ( /m i n )- -
10- MAY
12:06
80
0.0 0
120
93 80
X2
99 80
36.7
36.9 20
128
94 82 79
0
12
0 0
X1
P
150
50
200 80
MEDI 09:30
02:10
%SpO2
100 90
30 10 20S
ART
200 80
CVP
15
3
BPM
S
1HR
RPM
S
mmHg
M
mmHg
42.0
30.0
42.0
30.0
PR
80
T1
T2
TREND WINDOW SETUP
Set the trend display window that will show the real time wave window.
REV. 3.0 4.TREND 77
BM5 User’s Manual
TIME PERIOD
Set visible time period in a screen.
REV. 3.0 4.TREND 78
SET TREND PARA
Set parameter for display in a screen.
BM5 User’s Manual
TREND PRINT
Graphic: select the number which selects a graphic trend and press print to prints the selected
trend.
Table: select the table number to be print and press print to receive print all the data in the selected
patient admit (Admit) table.
REV. 3.0 4.TREND 79
5. ECG
5.1 Outline
Color and Name for Each Cable Size
ECG Connector Location and Measurement Cable
5 Lead Electrode Attached Location
3 Lead Electrode Attached Location
Method to Attach Electrode to Baby
5.2 ECG Data Window
5.3 ECG Data Setup
TRACE 1 LEAD SELECT
ALARM LIMIT
ALARM
QRS VOLUME
ECG SIZE
HEART RATE SOURCE
ECG SPEED
ANALYSIS SETTING
Rev. 3.0 5.ECG 80
5.1 Introduction
It calculates the heart rate with 3 or 5 leads or10 leads ECG signal acquisition and perform the alarm
according to the setting value.
Colors and Standards of Cables
AHAAmerican Heart Association (U.S.A. Certification)
IECInternational Electro technical Commission (Europe Certification)
3LEAD / 5LEAD
Leadwire
AHA
Color code
Right arm White RA Red R
Left arm Black LA Yellow L
Right leg Green RL Black N
Left leg Red LL Green F
V1(precordial) Brown V1 White C1
10LEAD
AHA
Leadwire
Color code
Right arm White RA Red R
Left arm Black LA Yellow L
Right leg Green RL Black N
Left leg Red LL Green F
V1(precordial) Brown(Red) V1 White(Red) C1
AHA
Label
AHA
Label
IEC
Color code
IEC
Color code
IEC
Label
IEC
Label
V2 Brown(Yellow) V2 White(Yellow) C2 V3 Brown(Green) V3 White(Green) C3 V4 Brown(Blue) V4 White(Brown) C4 V5 Brown(Orange) V5 White(Black) C5 V6 Brown(Purple) V6 White(Purple) C6
Rev. 3.0 5. ECG 81
BM5 User’s Manual
Position of ECG Connector and Measuring Cable
ECG connecter +detect cable
Attaching Electrodes to the Patient
1. Shave excess hair. With a piece of cotton pad moistened with alcohol, clean the patient’s skin
where the electrodes should be mounted. Avoid wrinkled or uneven skin areas. Wipe off the alcohol
with a dry cotton pad.
2. Open the electrode package and take out the electrode.
3. Remove the backing paper from the electrode. Be careful not to touch the adhesive side.
4. Attach the disposable electrode to the previously cleaned skin. Avoid wrinkled and uneven skin
areas.
5. The electrode lead which is connected to the monitor onto the electrode.
6. Fasten the electrode lead to the skin with surgical tape with an extra length of wire between the
tape and the electrode. This prevents body movement from moving the electrode lead.
Note
9 To maintain good contact between the electrode and skin, check that the paste of the
disposable electrode is not dry.
9 When contact of the disposable electrode becomes poor, replace the electrode with a new
one immediately. Otherwise, contact impedance between the skin and electrode increase
Rev. 3.0 5.ECG 82
BM5 User’s Manual
and the correct ECG cannot be obtained.
9 If the contact is bed before the expiration date on the package, replace the electrode with a
new one.
9 To obtain a stable ECG wave form rub the skin with “skin Pure” skin preparation gel or
tincture of Benzion.
9 Shall use only the CE certified disposable electrode.
Choosing an ECG lead for Arrhythmia Monitoring
It is very important to select a suitable lead for arrhythmia monitoring.
Guidelines for non-paced patients:
9 QRS should be tall and narrow(recommended amplitude > 0.5mV)
9 R wave should be above or below the baseline (but not bi-phasic)
9 T wave should be smaller than 1/3 R-wave height.
9 The P-wave should be smaller than 1/5 R-wave height.
For paced patients, in addition to the above,:
9 Not wider than the normal QRS
9 The QRS complexes should be at least twice the height of pace pulses.
9 Large enough to be detected, with no re-polarization.
To prevent detection of P-waves or baseline noises as QRS complexes, the minimum detection
level for QRS complexes is set at 0.15mV. Adjusting the ECG wave size on the monitor
display(gain adjustment)does not affect the ECG signal which is used for arrhythmia analysis. If the
ECG signal is too small, you may get false alarms for asystole.
Rev. 3.0 5.ECG 83
BM5 User’s Manual
Information on the ECG waveform
When ECG signal is 80bpm T-wave duration is 180ms, and the QT interval is 350ms.
10 Position of 10-Lead
5 Position of 5-Lead
Rev. 3.0 5.ECG 84
BM5 User’s Manual
Position of 3-Lead Wrier Electrode
How to Attach the NEONAT E Electrode
Rev. 3.0 5.ECG 85
5.2 ECG Data Window
BM5 User’s Manual
Heart Rate Alarm Limit:
Decides the QRS limits, and
gives an alarm if a value is over
the limits.
ECG Wave Display is always on when the cable is connected.
P
100
50
QRS: Detects QRS, and
flashes when QRS is
detected.
BPM
80
Note
Pace Detector Indicators:
Detects and displays
the patient’s pace
maker and flashes.
Heart Rate:
Displays heart rate per minute.
The heart rate is calculated by a moving average. The monitor detects 8 consecutive beats,
averages the R-R intervals of the latest 8 beats and uses this average to calculate the current
heart rate. When a new beat is detected, the heart rate is recalculated using the latest 8beats. The
heart rate display is updated every 3 seconds.
Heart rate meter updates a new heart rate for a step increase or decrease in 10 seconds maximum.
When ventricular tachycardia is detected, the alarm set in 5 seconds maximum.
Check that the delay time of the output signal (alarm trigger 80ms maximum) is within the range of
the connected equipment.
Rev. 3.0 5.ECG 86
BM5 User’s Manual
Safety Precautions
Warning
CABLES — Route all cables away from patient's throat to avoid possible strangulation.
CONDUCTIVE CONNECTIONS — Extreme care must be exercised when applying medical
electrical equipment. Many parts of the human/machine circuit are conductive, such as the
patient, connectors, electrodes, transducers. It is very important that these conductive parts do
not come into contact with other grounded, conductive parts when connected to the isolated
patient input of the device. Such contact would bridge the patient's isolation and cancel the
protection provided by the isolated input. In particular, there must be no contact of the neutral
electrode and ground.
DEFIBRILLATION — Do not come into contact with patients during defibrillation. Otherwise
serious injury or death could result.
To avoid the risk of serious electrical burn, shock, or other injury during defibrillation, all persons
must keep clear of the bed and must not touch the patient or any equipment connected to the
patient.
After defibrillation, the screen display recovers within 10seconds if the correct electrodes are
used and applied in accordance with the manufacturer’s instructions.
ECG cables can be damaged when connected to a patient during defibrillation. Check cables
for functionality before using them again.
The peak of the synchronized defibrillator discharge should be delivered within 60ms of the
peak of the R wave. The signal at the ECG output on the patient monitors is delayed by a
maximum of 30ms.
If the ECG waveform on the screen is too unstable to synchronize with the patient’s heart beat
because of the following reason, remove the cause of an alarm, message, or unstable ECG,
and then use a stable ECG lead for synchronization.
9 ECG electrode is detached or broken. Lead wire is detached or broken.
9 Lead wire moves. AC interference, EMG noise or noise from ESU is superimposed.
9 Connection cable is broken or has a short circuit. Connector has poor contact.
INTERFACING OTHER EQUIPMENT — Devices may only be interconnected with each other
or to parts of the system when it has been determined by qualified biomedical engineering
Rev. 3.0 5.ECG 87
BM5 User’s Manual
personnel that there is no danger to the patient, the operator, or the environment as a result. In
those instances where there is any element of doubt concerning the safety of connected
devices, the user must contact the manufacturers concerned (or other informed experts) for
proper use. In all cases, safe and proper operation should be verified with the applicable
Manufacturer’s instructions for use, and system standards IEC 60601-1-1/EN 60601-1-1 must
be complied with.
Electrosurgery Unit
9 Electrosurgical units(ESU) emit a lot of RF interference. If the monitor is used with an
ESU,RF interference may affect the monitor operation.
9 Locate the monitor as far as possible from the ESU. Locate them on opssite sides of the
operating table, if possible.
9 Connect the monitor and ESU to different AC outlets located as far as possible from each
other.
9 When using this monitor with an electrosurgical unit, its return plate and the electrodes for
monitoring must be firmly attached to the patient. If the return plate is not attached
correctly,it may burn the patient’s skin where the electrodes are attached.
Rev. 3.0 5.ECG 88
BM5 User’s Manual
5.3 ECG Data Setup
A setup window appears at lower part of the screen when the Trim Knob Key is pressed in the ECG
Parameter Window.
Selection is made by pressing the Trim Knob Key, while movement across the menu is performed by
turning the key either clock or anticlockwise.
LEAD SELECT
Select channels from I to V in ECG
Lead I, II, III show up in case of connecting 3-Leads ECG Cable.
Lead I, II, III, aVR, aVL, aVF, V show up in case of connecting 5-Leads ECG Cable.
LEAD 1 SELECT MENU
Rev. 3.0 5.ECG 89
LEAD 2 SELECT MENU
BM5 User’s Manual
Alarm Limit is 0 ~ 350.
MAIN
MENU
PREV
MENU
LEAD
SELECT
DISPLAY
ALARM
12LEAD
ECG
ANALYSIS
QRS
VOLUME :
OFF
ANALYSIS
SETTING
Rev. 3.0 5.ECG 90
BM5 User’s Manual
QRS VOLUME
Move the Key to select a volume rate from OFF, 10% to 100%.
MAIN
MENU
PREV
MENU
LEAD
SELECT
DISPLAY
DISPLAY
Set the sweep speed and waveform size.
MAIN
MENU
PREV
MENU
LEAD
SELECT
DISPLAY
ALARM
12LEAD
ECG
ANALYSIS
ALARM
12LEAD
ECG
ANALYSIS
QRS
VOLUME :
OFF
ANALYSIS
SETTING
QRS
VOLUME :
OFF
ANALYSIS
SETTING
ECG SWEEP SPEED
ECG speed is 25 mm/s.
Speed is changeable to 6.25, 12.5, 25, 50mm/s.
Rev. 3.0 5.ECG 91
BM5 User’s Manual
ECG SIZE
The size is changeable to X0.25, X0.5, X1, X2, X4.
MAIN
MENU
PREV
MENU
SWEEP SPEED : 25 mm/s
ECG
SIZE :
X1
VIEW ECG
The number of ECG wave could be configured with this function.
In case of 1 CH, there are 2 traces of 1 CH data at the ECG wave.
MAIN
MENU
PREV
MENU
SWEEP
SPEED :
25 mm/s
ECG
SIZE :
X1
VIEW
ECG
VIEW
ECG
MAIN
MENU
PREV
MENU
SWEEP
SPEED :
25 mm/s
VIEW
ECG
> 1CH
2CH 7CH 12CH
ANALYSIS SETTING
Analysis setting is divided to 3 menus.
MAIN
MENU
PREV
MENU
LEAD
SELECT
DISPLAY
ALARM
LIMIT
12LEAD
ECG
ANALYSIS
Rev. 3.0 5.ECG 92
QRS
VOLUME :
OFF
ANALYSIS
SETTING
BM5 User’s Manual
ECG FILTEROne may select from three frequency types for WAVE FILTER.
MONITOR 0.5Hz ~ 40Hz
MODERATE 0.5Hz ~ 25Hz
MAXIMUM 5Hz ~ 25Hz
DIAGONOSIS 0.05Hz ~ 150Hz
MAIN
MENU
PREV
MENU
ECG
FILTER :
MONITOR
ARRHYTH
LEVEL
PACE :
OFF
PVC
ANALYSIS:
ON
ARRHYTHMIA:
LETHAL
ST
SETTING
PACE:Sets up ON/OFF to indicate that the patient has PACE.
The PACE menu option enables/disables the pacemaker detection program.
MAIN
MENU
PREV
MENU
ECG
FILTER :
MONITOR
ARRHYTH
LEVEL
PACE :
OFF
PVC
ANALYSIS:
ON
ARRHYTHMIA:
LETHAL
ST
SETTING
MAIN
MENU
PREV
MENU
ECG
FILTER :
MONITOR
ARRHYTH
LEVEL
PACE :
ON
PVC
ANALYSIS:
ON
ARRHYTHMIA:
LETHAL
ST
SETTING
Be aware of the following when monitoring a patient with a pacemaker.
Rev. 3.0 5.ECG 93
BM5 User’s Manual
Warning
FALSE CALLS—False low heart rate indicators or false asystole calls may result with certain
pacemakers because of electrical overshoots.
MONITORING PACEMAKER PATIENTS—Monitoring of pacemaker patients can only occur
with the pace program activated.
PACEMAKER SPIKE—An artificial pacemaker spike is displayed in place of the actual
pacemaker spike. All pacemaker spikes appear uniform. Do not diagnostically interpret
pacemaker spike size and shape.
PATIENT HAZARD—A pacemaker pulse can be counted as a QRS during asystole in either
pace mode. Keep pacemaker patients under close observation.
PACEMAKER PATIENTS. Rate meters may continue to count the pacemaker rate during occurrences
of cardiac arrest or some arrhythmias. Do not rely entirely upon rate
meter
ALARMS. Keep pacemaker patients under close surveillance.
ARRHYTH: Sets up ON/OFF to indicate detection of diagnosis (Asys, VTAC/VFIB and VTAC).
OFF: Do not perform arrhythmia diagnosis.
LETHAL: Performs the detection of Asys, VTAC/VFIB, and VTAC at the selected lead
FULL: Performs the detection of all 13 arrhythmia.
The Analysis algorithm simultaneously uses leads I, II, III, and the V lead for ECG and arrhythmia
analysis.
Rev. 3.0 5.ECG 94
BM5 User’s Manual
ACC VENT Adult— Accelerated ventricular occurs when six or more ventricular beats are detected
with an average heart rate for the ventricular beat between 50 and 100 beats per minute.
0-2 years—Occurs when six or more ventricular beats are detected with an average heart rate for
the ventricular beat between 60 and 160 beats per minute.
3-10 years—Occurs when six or more ventricular beats are detected with an average heart rate for
the ventricular beat between 60 and 140 beats per minute.
11-13 years—Occurs when six or more ventricular beats are detected with an average heart rate for
the ventricular beat between 60 and 130 beats per minute.
ASYSTOLE
Ventricular asystole occurs whenever the displayed heart rate drops to zero.
BIGEMINY
Occurs when two or more bigeminal cycles (a ventricular beat followed by a non-ventricular
beat) are detected.
BRADY
Bradycardia is the average of the most recent eight R-to-R intervals at a heart rate less
than the set low heart rate limit.
NOTE
The Brady limit matches the low heart rate limit. If the low heart rate limit is changed, the Brady
limit changes.
COUPLET
Occurs when two ventricular beats are detected and have non-ventricular beats before and
after the couplet. The coupling interval must be less than 600 milliseconds.
IRREGULAR
Occurs when six consecutive normal R-to-R intervals vary by 100 milliseconds or more.
PAUSE
Occurs when the interval between two consecutive beats exceeds three seconds.
PVC
Isolated premature ventricular complexes occur when a premature ventricular beat is
Detected and has non-ventricular beats before and after.
Rev. 3.0 5.ECG 95
BM5 User’s Manual
R ON T
Occurs when a ventricular complex is detected within the repolarization period of a
Non-ventricular beat.
TACHY
Tachycardia is four R-to-R intervals at a heart rate greater than the set high heart rate limit.
NOTE
The Tachy limit matches the high heart rate limit. If the high heart rate limit is changed, the
Tachy limit changes.
TRIGEMINY
Occurs when two or more trigeminal cycles (a ventricular beat followed by two non-
Ventricular beats) are detected.
V BRADY Adult—Ventricular bradycardia occurs when a run of three or more ventricular beats is detected with
an average heart rate that is less than or equal to 50 beats per minute.
0-2, 3-10, and 11-13 years—Occurs when a run of three or more ventricular beats is detected with
an average heart rate that is less than or equal to 60 beats per minute.
VFIB/VTAC
Ventricular fibrillation occurs when the ECG waveform indicates a chaotic ventricular
arrhythm.
ST SETTING: ST signal and setting related ST menu.
ST ANAL YSIS: ON/OFF ST analysis signal.
Rev. 3.0 5.ECG 96
BM5 User’s Manual
MEASUREMENT CONDITION: ST measurement condition setting
TEMPLETE SELECT:
TEMPLETE SELECT: Select a Representative Lead of ST LEVEL.
The trace of the selected LEAD shows up at ST Window of POPUP TREND WINDOW
* In case of 3 Lead, this is fixed to Lead II.
Rev. 3.0 5.ECG 97
BM5 User’s Manual
PVC ANALYSIS: Decision maker to display PVC value sign with ON/OFF
MAIN
MENU
PREV
MENU
MAIN
MENU
PREV
MENU
ECG
FILTER :
MONITOR
ARRHYTH
LEVEL
ECG
FILTER :
MONITOR
ARRHYTH
LEVEL
PACE :
OFF
PVC
ANALYSIS:
OFF
PACE :
OFF
PVC
ANALYSIS:
ON
ARRHYTHMIA:
FULL
ST
SETTING
ARRHYTHMIA:
FULL
ST
SETTING
ARRHYTH LEVEL:
One can set up priorities when he or she uses the alarm for the diagnostic function.
Rev. 3.0 5.ECG 98
BM5 User’s Manual
12 CH ECG ANALYSIS
There are 5 sub-menus for 12 CH ECG ANALYSIS menu as following;
12LEAD ANALYSIS RUN
This is the start command of 12 CH ECG ANALYSIS.
REVIEW
This is result window to see the interpretation of 12 CH ECG.
There are 3 sub-menus for REVIEW menu
Rev. 3.0 5.ECG 99
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