1.1 CE Standard Information.........................................................................................................9
1.2 Read before Use.......................................................................................................................10
How to Contact Us .....................................................................................................................................10
1.4 Function and Key ....................................................................................................................37
External Function .......................................................................................................................................37
1.5 Standard Power Supply Application.....................................................................................39
DC Power ...................................................................................................................................................39
1.6 Battery Power Supply Application ........................................................................................40
Menu Selection...........................................................................................................................................45
Menu Composition .....................................................................................................................................45
Alarm for the Product.................................................................................................................................53
ALL LIMITS..............................................................................................................................................54
ALARM LIST ............................................................................................................................................56
SET PARA .................................................................................................................................................61
SET DATE & TIME...................................................................................................................................64
SET TIME ..................................................................................................................................................65
SET DATE..................................................................................................................................................65
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BM5 User’s Manual
COLOR SELECT.......................................................................................................................................65
SET SWEEP...............................................................................................................................................67
UNIT SELECT...........................................................................................................................................68
USER SERVICE ........................................................................................................................................69
SET UNIT NAME......................................................................................................................................69
SET BED NUMBER..................................................................................................................................69
AC FILTER................................................................................................................................................70
SYSTEM ....................................................................................................................................................70
TIME PERIOD...........................................................................................................................................75
TIME PERIOD...........................................................................................................................................78
SET TREND PARA...................................................................................................................................79
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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3
BM5 User’s Manual
How to Attach the NEONATE Electrode ...................................................................................................85
5.2 ECG Data Window..................................................................................................................86
5.3 ECG Data Setup ...................................................................................................................... 89
UNIT SELECT.........................................................................................................................................131
UNIT SELECT.........................................................................................................................................167
Ease of use................................................................................................................................................193
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.
Rev. 3.0 1.BASIC
25
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.
Rev. 3.0 1.BASIC
26
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.
Rev. 3.0 1.BASIC
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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.
Rev. 3.0 1.BASIC
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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.
Rev. 3.0 1.BASIC
34
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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35
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.
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 LIMITS:The machine enables one to see and change the limits of alarm for all parameter
functions.
ALARM PRINT:with an ON/OFF setup, the related information is printed out whenever an alarm is
given.
ALARM VOLUME:volume of each alarm can be adjusted in 10 step.
Rev. 3.0 2. PATIENT/DATA MANAGEMENT 53
Alarm
Text
BM5 User’s Manual
ALARM LEVEL:Priority 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
BM5 User Manual
3. SETUP
3.1 SETUP
DISPLAY
DEMO
USER SERVICE
MAKER SERVICE
Rev. 3.0 3.SETUP 60
BM5 User Manual
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 PARA:Measurement function selected.
WAVE SELECT:Set wave pattern source at the bottom of the WINDOW with LARGE
SET DATE & TIME: Set and change date and time.
HR/PR SOURCE:Set 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
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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.
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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.
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BM5 User Manual
4. TREND
4.1 TREND
GRAPHIC TREND
TABLE TREND
TREND WINDOW SETUP
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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
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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
BM5 User Manual
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
BM5 User Manual
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
AHA:American Heart Association (U.S.A. Certification)