Gima BM5 User manual
BM5 User Manual
Patient Monitor
Rev. 3.0
Rev. 3.0
BM5 User Manual
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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BM5 User’s Manual
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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BM5 User’s Manual
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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BM5 User’s Manual
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 Uт
U
т (60% dip in Uт
U
т (30% dip in Uт)
U
т (<95% dip in Uт
<5%
U
т (>95% dip in
т)
for 0.5cycle
40%
U
т (60% dip in Uт
)
for 5 cycle
70%
U
т (30% dip in Uт)
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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BM5 User’s Manual
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 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
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
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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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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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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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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.
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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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