Manual Ver: V1.3
Release Date: Feb. 2009
Part Number: MS1R-100381-V1.3
P/N:MS1R-100381-V1.3
Copyright
Copyright by EDAN Instruments, Inc. 2008-2009. All rights reserved.
Statement
This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User’s operation
failing to comply with this manual may result in malfunction or accident for which Edan
Instruments, Inc. (hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user shall
not disclose such information to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN is responsible for safety, reliability and performance of this equipment only in the
condition that:
• All installation, expansion, change, modification and repair of this equipment are conducted by
EDAN qualified personnel; and,
• Applied electrical appliance is in compliance with relevant National Standards; and,
• The monitor is operated under strict observance of this manual.
NOTE:
This equipment is not intended for family usage.
WARNING :
This monitor is not a device for treatment purpose.
It is important for the hospital or organization that employs this equipment to carry out a
I
reasonable maintenance schedule. Neglect of this may result in machine breakdown or injury of
human health.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, calibration
illustration list and other information to help qualified technician to maintain and repair some
parts, which EDAN may define as user serviceable.
Using This Label Guide
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in
personal injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure.
NOTE: A NOTE provides useful information regarding a function or procedure.
Revision History
This service manual shall be revised whenever changes in regulatory requirements dictate.
Patient Monitor (hereinafter called monitor) monitors parameters such as ECG, RESP, SpO2,
NIBP, dual-TEMP, dual-IBP, CO (Cardiac output), CO2 and GAS (Anesthetic gas), and is suitable
for adult, pediatric, and neonatal patients in a hospital environment and during patient transport
both inside and outside hospitals. The user can select different parameter configurations
according to different requirements.
It integrates the functions of parameter measurement module, display, record and output to
compose a compact, portable device. Its built-in replaceable battery provides convenience for
patient movement. On the high-resolution display screen, 7 waveforms and all the monitoring
parameters can be displayed clearly.
The POWER switch is on the left of the front panel (Figure 1-1, 1-2 ①). The POWER indicator
lights when the monitor is powered on (Figure 1-1, 1-2 ②). The CHARGE indicator shows the
charging status (Figure 1-1, 1-2 ③). The ALARM indicator flashes when the alarm is triggered
(Figure 1-1, 1-2 ④). The sockets of various sensors are on the left panel. Other sockets and
power plug-ins are on the rear panel. The recorder is on the right panel.
The monitor is a user-friendly device with operations conducted by a few buttons and the rotary
knob on the front panel (Figure 1-1, 1-2 ⑤⑥). Refer to Button Functions.
④
②
Power
Charge
MenuStartRecordSilenceFreezeMain
⑥
①
③
Figure 1-1 M9 Patient Monitor
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Patient Monitor Service Manual
③
②
Figure 1-2 M8 Patient Monitor
The monitor has six product models: M9, M9A, M9B, M8, M8A and M8B.
⑥
Product
Models
M9
M9A
M9B
Size(L×W×H)
Host:
322mm×150mm×285m
m
Host:
322mm×150mm×285m
m
Host:
320mm×150mm×265m
m
Shell Figure/
Screen Size
Round /
12 inches
Round /
10 inches
Square /
10 inches
Functions
ECG/RESP,
SpO2, NIBP,
TEMP, IBP,
CO, CO2,
GAS
ECG/RESP,
SpO2, NIBP,
TEMP, IBP,
CO, CO2,
GAS
ECG/RESP,
SpO2,
NIBP,
TEMP, IBP,
CO2
M8 Host: Square /
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ECG/RESP,
M8A
Patient Monitor Service Manual
320mm×150mm×265m
m
Host:
320mm×150mm×265m
m
12 inches
Square /
10 inches
SpO
2,
NIBP,TEMP
, IBP, CO2
ECG/RESP,
SpO
2,
NIBP,
TEMP, IBP,
CO2
M8B
Host:
320mm×150mm×265m
m
Square /
Wide_screen
10 inches
ECG/RESP, SpO2,
NIBP, TEMP,
IBP
Figure 1-3 M9 Patient Monitor
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Patient Monitor Service Manual
Figure 1-4 M9A Patient Monitor
Figure 1-5 M9B Patient Monitor
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Patient Monitor Service Manual
Figure 1-6 M8 Patient Monitor
Figure 1-7 M8A Patient Monitor
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Patient Monitor Service Manual
Figure 1-8 M8B Patient Monitor
The monitor can monitor the following parameters and waveforms:
ECG: Heart Rate (HR)
Maximum 7-channel ECG waveform
Arrhythmia and ST-segment analysis (optional)
RESP: Respiration Rate (RR)
Respiration Waveform
SpO2: Oxygen Saturation (SpO2), Pulse Rate (PR)
SpO2 Plethysmogram
NIBP: Systolic Pressure (SYS), Diastolic Pressure (DIA), Mean Pressure (MAP)
TEMP: Channel-1 Temperature (T1), Channel-2 Temperature (T2),
Temperature Difference between two channels (TD)
IBP: Channel-1 SYS, DIA, MAP
Channel-2 SYS, DIA, MAP
Dual-IBP waveforms
CO2: End Tidal CO2 (EtCO2)
Inspired Minimum CO2 (InsCO2)
Air Way Respiration Rate (AwRR)
CO2 waveform
CO: Blood Temperature (TB)
Cardiac Output (CO)
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Patient Monitor Service Manual
GAS: Inspired or expired CO2 (FICO2, ETCO2)
Inspired or expired N2O (FIN2O, ETN2O)
Inspired or expired O2 (FIO2, ETO2)
Inspired or expired Anesthetic Agent (FIAA, ETAA):
HAL (Halothame)
ISO (Isoflurane)
ENF (Enflurane)
SEV (Sevoflurane)
DES (Esflurane)
Airway respiration rate (respiring time per minute, rPM), AwRR
Minimal Alveolar Concentration (MAC)
4 anesthetic gas waveforms (CO2, N2O, O2, AA)
The monitor provides extensive functions such as visual and audible alarms, trend data storage,
NIBP measurements, alarm events, and drug dose calculation and so on.
1.2 Screen Display
The monitor is equipped with a high-resolution multicolor TFT LCD screen. The patient
parameters, waveforms, alarm messages, bed number, time, monitor status and other data can be
reflected from the screen.
The screen is divided into three areas:
1 Information Area ① ④;
2 Waveform Area ②;
3 Parameter Area ③.
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Patient Monitor Service Manual
① ② ③
Figure 1-9 Main Display
Information Area(①④)
The Information Area is at the top and bottom of the screen, displaying operation state of the
monitor and status of the patient.
The information area contains the following data:
Bed number of the monitored patient
ADU Type of patient. Three options: Adult, Pediatric, Neonatal
Name Name of the monitored patient, when the user inputs the patient name,
this name will be displayed on the right side of the patient type. If the
user doesn’t input the patient name, this position will be vacant.
06-16-2008 Current date
④
10: 22: 11 Current time
Indicates the status of mains power supply
means the main power supply is turned on,
means the main power supply is turned off.
Indicates the battery is equipped in the monitor and its capacity;
Gives information about the remaining battery charge, estimated
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Patient Monitor Service Manual
operation time and maintenance requirements;
means there is no battery equipped in the monitor.
Indicates the audio alarm is turned off.
Indicates the audio alarm pauses.
Displays beside parameter to indicate the alarm is turned off.
STANDBY Choose this item to enter Standby mode, the dialog pops up:
Figure1-10 Standby Mode
Select YES to enter the standby mode and display the current time; select NO, the monitor will
return to the main interface.
Other information of the Information Area comes up only with respective monitoring status. They
are:
n Signs indicating the operation status of the monitor and the sensors are displayed at the right
side of the patient name.
n Alarm message is displayed at the right most area.
n “FREEZE” appears when the waveforms are frozen.
Waveform Area (②)
Seven waveforms can be displayed at a time. The sequence of waveforms can be adjusted. Under
the maximum configuration, the system can display two ECG waveforms, one SpO2 waveform,
one Respiration waveform (can be from ECG module), two IBP waveforms and one CO
waveform.
2
In the TRACE SETUP menu, all the waveforms are listed. The user can select the waveform to
be displayed, and adjust the display position. Refer to Chapter 3.8 for details.
The waveform name is displayed on the upper left part of the waveform. The name of ECG is
user-selectable. Gain and filter way of this channel are displayed as well. A 1mv scale is marked
on the right of ECG waveform. The IBP waveform scale can also be selected according to the
actual requirement. Its range is described in the part: IBP Monitoring. In the IBP waveform area,
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Patient Monitor Service Manual
the waveform scale is displayed. The three dotted lines for each IBP waveform from top to down
represent respectively the upper limit scale, reference scale and lower limit scale. The values of
these three scales can be set. The specific method is given in the part: IBP Monitoring.
When a certain menu is displayed, some waveforms become invisible. Main display is restored
when you exit from the menu.
The user may set up the rate to refresh the waveform. The method to adjust the refreshing rate of
each waveform is discussed in the setup description of each parameter.
Parameter Area(③)
Parameter area is on the right of the Waveform area, and parameters are displayed corresponding
to waveforms basically. They are:
In normal status, the alarm indicator does not light.
When alarming, the alarm indicator lights or flashes. The color of the light represents the alarm
level. Refer to Chapter Alarm for details.
Refer to relative content of parameter for Alarm information and prompt.
Charge Indicator and Charge Status
To indicate the status of charging: When the battery is charged, the light color turns into orange.
1.3 Button Functions
All operations to the monitor can be finished by several buttons and a knob. They are:
① Menu
② Start
③ Record
④ Silence
…
Figure 1-11 Buttons
Press it to call up the SİSTEM MENÜ. Refer to Chapter
SYSTEM MENU and Chapter Trend and Event for details.
Press it to fill air into cuff and start blood-measurement. During
the measurement process, press the button to stop measurement.
Press it to start real-time recording. The recording time is set in
RT REC TIME of RECORD submenu.
When the SYSTEM MENU→ MAINTAIN → USER
MAINTAIN → ALARM SETUP is set to ON, Press this button
to silence the alarm. All the alarm audio will be turned off. At the
same time, “Alarm Pause ×× s” and will be displayed in the
Information area. When you re-press it or the pause time is over,
the system will resume the normal monitoring status. And
“Alarm Pause ×× s” and icon will vanish.
Pressing and holding this button for more than 3 seconds can turn
off the audio alarm. is shown in the Information area.
Pressing or holding the button again can resume the alarm.
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Patient Monitor Service Manual
NOTE:
Whether alarms will be reset depends on the status of the
alarm cause. But pressing SILENCE button (suspend
alarm) can permanently shut off audio of the Lead Off or
Sensor Off alarms. So the user can exit from the Alarm
Silence Status by Technical Alarm.
⑤ Freeze
⑥ Main
⑦ Rotary Knob
Method of Using the Knob to Operate on the Screen:
The rectangular mark on the screen that moves with the rotation of the knob is called “cursor”.
Operation can be performed at any position where the cursor stays.
When the cursor is in the waveform area, the user may immediately modify the current setup.
When the cursor is in the parameter area, the user may open the setup menu of the corresponding
parameter module so as to set up the menu items of the module.
Operation method:
In normal mode, press this button to freeze all the waveforms on
the screen. When in FREEZE mode, press it to restore the
waveform refreshment.
Press it to return to the main interface.
The user can use the rotary knob to select the menu item and
modify the setup. It can be rotated clockwise or anticlockwise
and pressed. The user can use the knob to realize the operations
on the screen, in the SYSTEM MENU and parameter menu.
■ Move the cursor to the item where the operation is required.
■ Press the knob.
■ One of the following four situations may appear:
1. The cursor with background color may become a frame without background color,
which implies that the content in the frame can change with the rotation of the knob.
2. Menu or measurement window may appear on the screen, or the original menu is
replaced by the new menu.
3. A check mark “√” appears at the position, indicating that the item is confirmed.
4. The system immediately executes a certain function.
1.4 Interfaces
For the convenience of the operator, interfaces of different functions are located in different sites
of the monitor.
Right Side of the Monitor
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Patient Monitor Service Manual
②
At the right side of the monitor, there are the bracket of water trap for CO2 module and the
Anesthetic gas module water slot (①), and the recorder’s paper inlet cover (②).
①
Figure1-12 Right Panel of M9, M9A
①
②
Figure1-13 Right Panel of M9B, M8, M8A and M8B
Left Side of the Monitor
Connectors for cables and sensors are as shown in the following figure.
1. Air inlet
2. CO2 sensor connector
3. IBP1 transducer connector
4. ECG cable connector
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5. NIBP cuff connector
4
5
1
2
!
6
6. Air outlet
7. TEMP1 probe connector
8. TEMP2 probe connector
9. IBP2 transducer connector
10. CO sensor connector
11. SpO2 sensor connector
Patient Monitor Service Manual
2
CO
1
T
7
T2
8
IBP1
3
ECG
IBP2
9
CO
10
2
NIBP
pO
S
11
Figure 1-14 Left Panel
This symbol means “BE CAREFUL". Refer to the manual.
This symbol indicates that the instrument is IEC/EN60601-1 Type BF equipment, of defibrillation
type.
This symbol indicates that the instrument is IEC/EN60601-1 Type CF equipment. The unit
displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high
degree of protection against shock, and is suitable for use during the defibrillation.
Rear Panel
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Patient Monitor Service Manual
Figure 1-15 Rear Panel of M9 and M9A
①
②
Figure 1-16 Rear Panel of M9B, M8, M8A and M8B
③
④
Sockets on the rear panel are shown in Figure 1-15, 1-16.
① Network Interface (reserved): Standard RJ45 Socket, for connecting to MFM-CMS of EDAN.
② Equipotential grounding terminal for connection with the hospital’s grounding system.
③ Fuse box, used to put fuse.
④ Power supply socket: AC100-240 V, 50/60 Hz.
⑤ Probe Holder (optional), used to place various types of probes.
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Patient Monitor Service Manual
1.5 Built-in Rechargeable Battery
The monitor is equipped with a built-in chargeable battery. When switching on AC power supply,
the battery will be charged automatically until the electric energy becomes full. There is a sign
“” in the lower left corner of screen to show the charging status, and the green part is
the electric energy of battery. When the monitor is not equipped with battery, the battery status
will be showed as the sign “”, which means no battery.
One battery can power the monitor. Under the cable connectors is the cover of battery
compartment. See Battery compartment in the following figure.
The charging time for battery resuming to 90% of electric energy is about 150min for 2Ah, and
360min for 4Ah.
OPEN
Figure 1-17 Battery Compartment
Replacing Battery
When the lifespan of battery is over, or foul odor and leakage has been detected, please contact
the manufacturer or local distributor for replacement of battery.
WARNING
Do not unplug the battery during monitoring. When the AC power supply is switched off
unexpectedly, the device will not be affected, if it has a standby battery.
WARNING
Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal
condition is detected during use, charge, or storage. Keep it away from the monitor.
WARNING
Make sure the device is used in the appointed range of voltage, and the effect of power
supply can be not noticeable.
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Patient Monitor Service Manual
supply
part
part
2 Principle
2.1 General Parts
The monitor has been designed to measure physiological parameters including ECG, RESP,
TEMP, NIBP, SpO2, IBP, CO2, CO and GAS.
There are five parts in Patient Monitor, see figure 2-1.
• Parameter measurement part
• Main control part
• Interface part
• Power supply part
• Other auxiliary parts
Main
control
part
Interface part
Power
Parameter
measurement
Other auxiliary parts
Figure 2-1 Monitor Structure
2.1.1 Parameter Measurement Part
The Patient Monitor acquires the physiological signals of ECG, respiration, non-invasive blood
pressure (NIBP), oxygen saturation of the blood (SpO2), temperature (TEMP), invasive blood
pressure (IBP), cardiac output (CO), CO2 and Anesthetic gas (GAS). The Parameter
Measurement Part can transform the physiological signals to the electrical signals, and process
signals and transfer the values, waveforms and alarm information to the Main Board, and display
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Patient Monitor Service Manual
them on the Interface Board.
2.1.2 Main Control Part
The main board consists of Interface board and Core board. It has CPU/memory, display circuit,
network circuit and I/O interface. Main board of the integrated board is used to drive
man-machine interface, manage parameter measurement and provide other specific functions to
the user such as configuration storage, waveform and data recall and so on.
2.1.3 Interface Part
The man-machine interface consists of the TFT display, a recorder, a speaker, an indicator, keys
and knob.
The high-resolution TFT display is the most primary output interface, displaying real-time or
history data and waveforms, various patient information and alarm prompts on the screen for the
user’s observation.
The recorder is an auxiliary device compared with the interface, which could print out various
user-selected data for usage and preservation.
The speaker gives heart beat tones and audio alarms.
The indicator provides additional information about power supply, battery and alarm.
The keys and knob are user input interface of the system and the user could input information and
instructions into the monitor through them.
2.1.4 Power Supply Part
Power supply is an important part of the system, consisting of power board, power switch board,
battery and fan.
The main power board converts the AC mains input into 5V and 12V DC to energize other parts
of the system. Similarly TFT display requires particular supply, for this reason a power switch
board is supplied. The battery could maintain the formal function of the system for a short period
when AC mains supply is disconnected. A small fan requiring DC input is used to realize superior
ventilation.
2.1.5 Other Auxiliary Parts
RJ45 on-line upgrade port is available on the monitor, which allows the service engineer to
upgrade the system software without opening the enclosure of the monitor. This port is NET
function.
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Patient Monitor Service Manual
2.2 Hardware Functional Principle
The following figure shows the hardware structure of the whole monitor as well as the connection
relationships between different parts. The board in the center of the figure is the core part of the
monitor, i.e., integrated board for main control and parameter measurement, which, though being
a single board, could realize the measurements of five parameters mentioned.
Figure 2-2 M9/M9A Structure and Part Relationship
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Patient Monitor Service Manual
LCD
NIBP
Inverter
control
Power control
board
Network
board
Backlight
Signal
Fan
Battery
RJ45
Port
Power module
board
Keyboard
Speaker
Nurse call
Recorder
SpO2 module
CO2 module
SpO2 sensor
CO2 sensor
2410
CO sensor
Main
board
Driver
Board
CO/IBP module
ECG module
module
IBP sensor
ECG sensor
TEMP sensor
Air pump,
Valve, Cuff
Figure 2-3 M9B/M8/M8A/M8B Structure and Part Relationship
NOTE:
The Nurse call board and the Network board are optional configuration, they can not be
installed at one time. If you want to use the Nurse call function, you should install the
Nurse call board, otherwise you should install the Network board.
2.2.1 Power Module
This module provides DC supplies to other boards.
Schematic Diagram
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Patient Monitor Service Manual
∽AC
Power Module
P23P22
P33P32
POWER
CONTROL
BOARD
P21
P31
+5V
GND
P4
+12V
-12V
J1
J2P7
Figure 2-4 Schematic Diagram of the Power Board
Principle Introduction
This module converts 220V AC mains power supply or battery power into 5V, 12V and -12V DC
supplies to power other boards. If AC mains and battery coexist, the former take the priority to
power the system and charge the latter at the same time.
AC/DC
Converts high-voltage AC supply into low-voltage DC supply to power subsequent circuits and
charge the battery.
Battery Control Circuit
If AC supply and battery coexist, this circuit controls the output from AC/DC part to charge the
battery. If AC supply is disconnected, this circuit controls the battery to power the subsequent
circuits.
5V DC/DC
Convert the DC supply from the previous circuit into stable 5V DC supply to power other boards.
12V/-12V DC/DC
Converts the DC supply from the previous circuit into stable 12V/-12V DC supply to power other
boards.
Power Switch Circuit
Controls the working status of 5V DC/DC and 12V DC/DC in order to control ON/OFF action of
the patient monitor.
Voltage Detection Circuit
Detect the output voltage of every part in detection circuit, convert analogue signals to digital
signals and then send them to Main board for processing.
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Patient Monitor Service Manual
2.2.2 Main Board
Main board is the heart of the monitor and it can do system control, system adaption, system
management, data processing, file management, display processing, printer management, data
storage, system diagnosis, fault alarm, etc.
Main board schematic diagram
Three Serial Ports
LCD controller
AC97 Sound card
Extended
periphery
16c554, 16c552
Figure 2-5 Schematic Diagram of Main Board
CPU System
CPU is the kernel of ARM9 and it is the core part of the Main board. CPU connects with other
periphery modules via buses and I/O cables. It can realize data communication, data processing,
logical control and other functions.
RTC
RTC can offer second, minute, hour, day, month, year and other calendar information. CPU can
gain such calendar information from RTC and can also rewrite the data in RTC.
Ethernet Controller
Ethernet controller supports IEEE 802.3/IEEE 802.3u Ethernet standard, supports 10Mbps and
100Mbps data transmission rate. CPU exchanges data with Ethernet via Ethernet controller.
LCD Controller
LCD controller can control LCD display.
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Patient Monitor Service Manual
2.2.3 Keyboard
This module acts as a man-machine interface.
Schematic Diagram
Figure 2-6 Schematic Diagram of Keyboard
Introduction to Principle
This module detects key and encoder input signals, converts them into codes and sends to Main
board. Main board sends commands to the keyboard and the latter accordingly controls the alarm
indicator state.
CPU
Detect key and encoder input signals;
Control LED status;
Regularly zero Watchdog Timer;
Communicate with Main board.
Audio Process Circuit
Advance audio signals to drive the speaker to give sound.
Watchdog
Upon power-up, supply Reset signal to CPU;
Provide functions of Waterdog Timer Output and voltage detection.
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