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Edan M8 PDF
Edan M8 PDF
P/NMS1R-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. Users 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.
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.
Revision History
This service manual shall be revised whenever changes in regulatory requirements dictate.
Date
ECO
Version
Revision history
ECO-MPM-8003
V1.0
1st edition
ECO-MPM-8005
V1.1
ECO-MPM-8013
V1.2
V1.3
II
Table of Contents
1 Introduction ................................................................................................................................. 1
1.1 General Information ............................................................................................................... 1
1.2 Screen Display........................................................................................................................ 7
1.3 Button Functions................................................................................................................... 11
1.4 Interfaces .............................................................................................................................. 12
1.5 Built-in Rechargeable Battery .............................................................................................. 16
2 Principle ..................................................................................................................................... 17
2.1 General Parts......................................................................................................................... 17
2.1.1 Parameter Measurement Part........................................................................................ 17
2.1.2 Main Control Part ......................................................................................................... 18
2.1.3 Interface Part................................................................................................................. 18
2.1.4 Power Supply Part ........................................................................................................ 18
2.1.5 Other Auxiliary Parts .................................................................................................... 18
2.2 Hardware Functional Principle............................................................................................. 19
2.2.1 Power Module ................................................................................................................ 20
2.2.2 Main Board .................................................................................................................... 22
2.2.3 Keyboard ........................................................................................................................ 23
2.2.4 Recorder Module............................................................................................................ 24
2.3 Software Function Principle ................................................................................................. 25
2.3.1 System Software ............................................................................................................ 25
2.3.2 System Software Function ............................................................................................. 25
2.4 System Parameters................................................................................................................ 26
2.4.1 General ........................................................................................................................... 26
2.4.2 ECG/RESP ..................................................................................................................... 27
2.4.3 NIBP............................................................................................................................... 29
2.4.4 SpO2............................................................................................................................... 30
2.4.5 TEMP ............................................................................................................................. 30
2.4.6 IBP ................................................................................................................................. 31
2.4.7 CO .................................................................................................................................. 31
2.4.8 CO2 ................................................................................................................................. 31
2.4.9 GAS................................................................................................................................ 32
2.4.10 Data Storage Function.................................................................................................. 32
3 Installation of Monitor.............................................................................................................. 34
3.1 Open the Package and Check ............................................................................................... 34
III
IV
1 Introduction
1.1 General Information
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 ). The POWER indicator
lights when the monitor is powered on (Figure 1-1, 1-2 ). The CHARGE indicator shows the
charging status (Figure 1-1, 1-2 ). The ALARM indicator flashes when the alarm is triggered
(Figure 1-1, 1-2 ). 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 ). Refer to Button Functions.
Power
Main
Freeze
Silence
Record
Start
Menu
Charge
-1-
The monitor has six product models: M9, M9A, M9B, M8, M8A and M8B.
Product
Shell Figure/
Screen Size
SizeLWH
Models
Host:
M9
Round /
322mm150mm285m
m
Host:
M9A
Round /
322mm150mm285m
m
Host:
M9B
M8
12 inches
10 inches
Square /
320mm150mm265m
m
10 inches
Host:
Square /
-2-
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
ECG/RESP,
320mm150mm265m
m
Host:
M8A
M8B
12 inches
Square /
320mm150mm265m
m
10 inches
Host:
Square /
320mm150mm265m
m
10 inches
Wide_screen
-3-
SpO2,
NIBP,TEMP
, IBP, CO2
ECG/RESP,
SpO2,
NIBP,
TEMP, IBP,
CO2
ECG/RESP, SpO2,
NIBP, TEMP,
IBP
-4-
-5-
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:
CO2:
CO:
GAS:
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.
-7-
Information Area( )
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
Name
06-16-2008
Current date
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
-8-
Choose this item to enter Standby mode, the dialog pops up:
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 ()
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 CO2
waveform.
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,
-9-
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()
Parameter area is on the right of the Waveform area, and parameters are displayed corresponding
to waveforms basically. They are:
ECG:
Heart Rate (Unit: beats per minute, bpm)
ST-segment analysis of Channel 1 & 2ST1, ST2 (Unit: mV)
PVCs (Premature Ventricular Contraction) events (Unit: event/min)
SpO2:
Oxygen Saturation SpO2 (Unit: %)
NIBP:
(From left to right) Systolic pressure, Mean pressure, Diastolic pressure (Unit: mmHg or
kPa)
TEMP:
Temperature of channel1, channel2 and their temperature difference: T1, T2, TD (Unit:C
or F)
RESP:
Respiration Rate (Unit: breath/min)
IBP:
The blood pressure of channel 1 and 2. From left to right, there are Systolic pressure,
Mean pressure and Diastolic pressureUnit: mmHg or kPa)
CO2:
EtCO2 (Unit: %, mmHg or kPa)
INS CO2 (Unit: %, mmHg or kPa)
AwRR (Unit: times/minute)
CO:
CO (Unit: liter/minute)
TB (Unit: C or F)
GAS:
Airway Respiring Rate (Respiring per minute)
Minimal Alveolar Concentration.
Alarm Indicator and Alarm Status
- 10 -
Menu
Start
Record
Silence
- 11 -
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.
Freeze
Main
Rotary Knob
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.
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
- 12 -
At the right side of the monitor, there are the bracket of water trap for CO2 module and the
Anesthetic gas module water slot (), and the recorders paper inlet cover ().
T1
7
T
2
P
IB
IB
3
O
C
4
2
O
p
S
5
6
IB
10
11
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
- 14 -
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
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
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.
- 16 -
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.
Interface part
Interface part
Main
control
Power supply
part
part
Parameter
measurement
part
- 18 -
- 19 -
Power module
Power control
board
RJ45
Port
Keyboard
2410
Speaker
Main
control
board
SpO2 module
SpO2 sensor
CO2 module
CO2 sensor
CO sensor
CO/IBP module
IBP sensor
ECG sensor
Nurse call
board
ECG module
Network board
NIBP module
TEMP sensor
Inverter
Driver
Board
Backlight
Signal
Air pump,
Valve, Cuff
LCD
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.
- 20 -
AC
Power Module
+5V
+12V
GND -12V
P23P22 P21
P33P32 P31
P4
POWER
CONTROL
P7
BOARD
J1
J2
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.
- 21 -
LCD controller
Extended
periphery
16c554, 16c552
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.
- 22 -
2.2.3 Keyboard
This module acts as a man-machine interface.
Schematic Diagram
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.
Watchdog
Upon power-up, supply Reset signal to CPU;
Provide functions of Waterdog Timer Output and voltage detection.
- 23 -
Introduction to Principle
This module receives printing data from Main board and converts the data into dot matrix data
and sends them to the thermal printer. It can also drive the printer to perform printing action.
Step Motor Drive Circuit
A step motor is used in the printer to feed paper. This circuit is designed to drive the step motor to
act.
Printer Status Detect Circuit
Detect the status of the printer and send the information to CPU, including the position of paper
platen, whether there is paper, and temperature of the thermal head.
CPU System
Process printing data;
Control printer and step motor;
Collect printer status information and realize corresponding control;
Communicate with Main board.
- 24 -
Parameter
Para.
data
Data
analyse
analyse
Parameter
measurem
Alarm
Display
output
Display
screen
Printer
output
Printer
Parameter
ent
Classify/
Module
process
Central
Monitoring
System
Network
Data
LUNIX
Core
Input
Network
Network
Data
Data
analyse
analyse
Alarm
control
Network
LUNIX
Core
Viewbed
data
analyse
Network
data
Send out
User
Input
GUI
responsion
Interface
Output/
Control
Analog
output
Alarm
indicator/
speaker
Analog
output
It indicates the software system in the above frame. On the left of the frame is software system
input, and on the right is software system output. Parameter measurement module exchanges data
with software system via serial ports, while the user communicates with the system via the
keyboard. The recorder and alarm devices receive data via serial ports. The analogue output
apparatus is MBUS, screen and network controller are controlled by CPU directly.
Task Name
Task Function
Performance
Cycle
System
initialization
Once after
POST
Parameter
process
Real-time
data
data
- 25 -
processing
Timing information
display
Once
second
Module
and
interface transform
task
Interface
change task
With
task
key
System monitor
System monitor,
management task
Once
second
per
Central Monitoring
System
network
connection
Network
processing
data
voltage
monitor,
battery
per
Once per 5
seconds
Once
second
per
per
Cardioelectric
analysis task
Once
second
10
Printer task
Have record
task
11
Parameter
processing task
12
Watchdog task
and
response
Real-time
processing
Once
second
per
keyset. The keyset can also realize power switching and conversion. The whole system structure is
show in the figure below:
Medical staff
Keyboard
Monitor
Power supply
Main board
ECG /
RESP /
TEMP
NIBP
SpO2
Recorder
Keyboard
IBP / CO
CO2
GAS
Patient
Figure 2-9 System Structure
As shown in the above figure, the eight parameter modules execute real-time monitoring to
Non-invasive blood pressure, SpO2, ECG / Respiration / Temperature, Invasive blood pressure /
Cardiac Output, CO2 and GAS respectively through cuff and measurement cables. The results can
be sent to Main board to process and display, and they can also be sent to recorder for output and
printing. The function details of Parameter monitor will be explained in the following sections.
2.4.2 ECG/RESP
1. ECG
ECG module detects low voltages of about 1 mV that appear on the skin as a result of cardiac
activity. Three or five electrodes arranged in standard configurations are called leads and placed on
the skin to sense these voltages. Two electrodes are required for one ECG lead at least and the third
electrode is used as a reference to reduce electrical interference. Each lead can present ECG
waveform whose P waves, QRS complex, and T waves vary in amplitude and polarity. The signals
from the different leads provide the cardiologist with a complete representation of the electrical
- 27 -
activity of the heart, including the HR, which is interpreted as the R-to-R Interval. The timing and
wave shape of ECG provide information on whether the patients HR is characterized by
arrhythmia or other altered functions requiring treatment. The ECG is also used to monitor the
effects of infusing antiarrhythmia or cardiotonic agents. Blood pressure, the force exerted by the
blood against the blood vessel walls, is more reliable than an ECG signal in assessing effective
pumping blood of the heart and the flexibility of blood vessel.
The main functions concerning ECG of Patient Monitor:
a. Lead: 3-lead, 5-lead;
b. Lead method: I, II, III, AVR, AVL, AVF, V
c. Float input
d. Right-leg drive
e. Lead-off detection
f. Dual-channel ECG amplification, simultaneously processing ECG signals of any two
leads.
The ECG circuit is responsible for processing the ECG signals from human body and consists of
the following parts:
a. Input circuit: the ECG electrodes are connected into the circuit through the cables.
This circuit is mainly used to protect ECG input phase and filter the signals to remove
the outside interference.
b. Buffer amplifying circuit: it is used to convert the impedance of ECG signals in order
to ensure that the ECG has very high input impedance but very low output impedance.
c. Right-foot drive circuit: the middle output point of the buffer amplifying circuit is
reversely amplified and then fed to the RL of the 5-lead ECG to maintain the human
body in a equipotential state. This method can reduce the interference and raise the
common-mode rejection ratio of the circuit.
d. Lead-off detection: based on the theory that the lead-off may cause the output
potential of the buffer amplifying circuit to change, we can use the comparator to
accurately determine if the lead has fallen off. In this way, the level can also be
converted into TTL level for the singlechip to test.
e. Lead connection circuit: under the control of singlechip and as per requirement, we
can connect different lead electrodes into the main amplifying circuit for
amplification.
f. Main amplifying circuit: a measurement amplifier constructed by three standard
operation amplifiers.
g. Next phase processing circuit: is mainly used to couple ECG signals, program-control
the magnitude of the gain, filter the waveform and move the level, amplify the signal
and send it to the Analog-to-Digital converter.
is working
d.
This function is active in 5-lead mode only.
3. RESP
When a person is respiring, his chest goes up and down. This action equals the impedance
changes between electrodes RA and LA. The monitor converts the high-frequency signals
passing through RA and LA into amplitude-modulated high-frequency signals, which are
demodulated and amplified into electric signals varying with the respiration changes and
transmitted to Analog-Digital Converter. RESP module is made up of a respiration circuit board
and a coupling transformer. The circuit includes those parts such as oscillation, coupling,
demodulation, preliminary amplification, and high-gain amplification, etc.
2.4.3 NIBP
Blood pressure monitors commonly measure arterial pressure, which is produced by the
contractions of the heart and constantly changes over the course of cardiac cycle. Three blood
pressure values, expressed in millimeters of mercury above atmospheric pressure, are typical
obtained. The systolic pressure is the maximum cycle pressure; which occurs during ventricular
contraction. The diastolic pressure is the minimum cycle pressure, occurring during the
ventricles filling stage between contractions. The means arterial pressure (MAP) is the mean
value of the blood pressure over the cardiac cycle.
The monitor measures non-invasive blood pressure using the oscillometric method. Following are
detailed measurement procedures. Inflate the cuff encircling the upper arm until the pressure in
the cuff blocks the blood flow in the artery of the upper arm. Then deflate the cuff gradually
according to the requirement of certain arithmetic. With the decreasing of the pressure in the cuff,
the artery blood will palpitate with the pulse, which results in palpitation in the cuff. Through the
pressure sensor connected with the inflating pipe of the cuff, a palpitation signal palpitating with
the pulse will be generated. After being filtered by a high-pass filter (about 1Hz), this signal
becomes pulsating signal and is amplified. Then the amplified signal is converted into digital
signal by A/D. After using the single chip to process this digital signal, we may obtain systolic
pressure, diastolic pressure and mean pressure. Be careful to choose appropriate cuffs for
neonatal, pediatric and adult patients so as to avoid generating measurement error. NIBP module
also has protection circuit to prevent the cuff from being inflated to a very high pressure. The
following are the main operating modes of NIBP.
a. Adult/pediatric/neonate: select it based on the patient weight and age.
b. Manual measurement, auto measurement, continuous measurement: Manual measurement
is also called single measurement. It means the monitor only performs one measurement
for each time. Auto measurement means to perform one measurement within selected
cycle. Time interval can be set to 1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 240 and 480 minutes.
Continuous measurement means after being activated, the monitor will perform quick
measurement continuously within 5 minutes. Continuous measurement is effective in
monitoring changes in blood pressure.
The main functions concerning NIBP pulse rate are shown as below:
a. Interface: NIBP pulse rate switch. The PR setup switch on the NIBP parameter setup
- 29 -
2.4.4 SpO2
SpO2 measurement employs the principle that the absorption of pulse blood oxygen to red and
infrared light by means of finger sensor and SpO2 measurement unit. The light-electronic
transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood
oxygen into electrical signal, the signal is processed by hardware and software of the unit. The
PLETH curve and numeral value of SpO2 will be obtained.
By tracing the pulse waveform on the fingertip, using specified arithmetic and consulting the
clinical data table, we can obtain the SpO2 value. The SpO2 sensor consists of two LEDs and a
photodetector. The two LEDs are respectively red diode and infrared diode, which are lighted on
according to certain time sequence. When the capillary vessel of the fingertip congests repeatedly,
the light of the LED is absorbed by blood vessels and organs and then projected onto the
photodetector. The photodetector can detect the light intensity varying with pulse changes and
display the changing light intensity in the form of changing electronic signals. The ratio between
the DC and AC of the two types of signals for light is the % oxygen in the blood. Then we can
calculate correct SpO2 value by using specified arithmetic and also calculate pulse rate according
to the SpO2 waveform.
The SpO2 module mainly consists of the sensor, the signal processing, the control unit of LED
driving sequence and the singlechip.
2.4.5 TEMP
Body temperature is measured by means of a thermistor probe (a semiconductor whose resistance
changes with temperature) that is layed on the oxter.
The temperature of human body is first converted into electronic signals, which are then
amplified by amplifier and processed. In this way we can obtain the TEMP value. The circuit
includes proportional amplifier constructed by operational amplifiers. The temperature passes the
thermal sensor, producing pressure signals, which are amplified and transmitted to A/D converter
- 30 -
for further processing. Sensor detection circuit includes voltage comparator constructed by
operational amplifiers. When disconnecting the sensor, the input voltage is lower than the
comparative pressure, therefore the voltage comparator outputs low level. When connecting the
sensor, the input voltage is higher than the comparative pressure, therefore the voltage
comparator outputs high level.
2.4.6 IBP
IBP is measured by means of a catheter inserted directly into the circulatory system. A pressure
transducer connected to the catheter converts the mechanical force exerted by the blood into an
electrical signal, which is displayed graphically as pressure versus time on a monitor screen or
numerically on digital display. IBP monitors arterial blood pressure, central venous pressure and
pulmonary arterial pressure and other parameters.
Measurement method:
Stab and implant the catheter into blood vessel of part to be measured, catheters port outside
body connects directly with pressure transducer. Inject saline into catheter. Because the liquid can
transfer pressure, so the blood pressure inside blood vessel can be transferred to exterior pressure
transducer via inner catheter liquid. So real-time dynamic waveforms for changing pressure
inside blood vessel can be acquired, through specified calculation method, we can gain systolic,
diastolic, mean arterial pressure.
2.4.7 CO
Thermal dilution is the method widely used to measure CO. Insert the floating catheter into the
pulmonary artery by passing the right atrium. Then use this catheter to injectate normal saline
into the right atrium. A temperature sensor is installed at the front end of the catheter. When the
cold liquid of normal saline mixes up with the blood, temperature will change. Therefore, when
blood after mix-up enters the pulmonary artery, the temperature sensor can detect the change.
According to the time of infusing normal saline and temperature changes after mixing up, the
monitor can calculate CO and cardiac index, stroke index of both left and right ventricles, and
resistance in pulmonary blood vessels, etc.
2.4.8 CO2
The measure of CO2 is based on infrared absorption characteristic of CO2 module. CO2 molecule
can absorb 4.3m infrared ray. Absorption intensity is proportional to CO2 concentration of
patient sample, the CO2 concentration will compute from the detecting CO2 absorption intensity
of patient sample. The relation between partial pressure and percentage of CO2 concentration is
given below:
P (mmHg) = Percentage (%) Pamp (ambient pressure )
There are Mainstream and Sidestream modules according to different connecting way of infrared
sensor. Sidestream module consists of circuit board, built-in sidestream infrared sensor, air pump
and control unit. When using Sidestream, the user should also use exterior water trap, dry tube
- 31 -
and sampling tube; Mainstream consists of circuit board and external mainstream infrared sensor.
IR sensor requires preheating; in Sidestream mode, the pumping rate can be set as 100, 150 or
200 ml/min according to patient situation, and the user can set up compensation in anesthetic
monitoring, such as water vapor, oxygen, temperature, Des, etc. when not performing CO2, it is
recommended to close Sidestream air pump, Mainstream module sensor and IR source, for
extending the lifespan of module and reducing power consumption. In Mainstream mode, IR
preheating time is relative long, and the module has no air way like that of Sidestream.
2.4.9 GAS
Concentration of GAS (Anesthetic gas) is measured for its characteristic of absorbing infrared ray.
All the anesthetic gases measured in AG module have this characteristic, and each gas has its
own absorption characteristic. First the gas to be measured is driven into a sample cell. Then
optic infrared filter selects the infrared ray with special wavelength to penetrate this gas. For a
given volume, the higher gas concentration is, the more infrared rays are absorbed. It means the
higher the concentration of the absorbed infrared is, the fewer infrared rays penetrated the gas.
First measure the quantity of infrared rays that have penetrated the gas and then calculate the gas
concentration via specialized formula. For multiple gases measuring, it need install various
infrared filters in AG module.
For measuring O2, we apply Galvanic oxygen sensor. Through the oxidation and deoxidation
reaction the sensor can produce current, so we can measure the current to calculate the O2.
both patient ID interface and patient data interface. They are used to delete all data and patient ID
data respectively. [Delete all data] can delete all patients data including data from network
package data. [Delete Patient ID data] can delete the data about this patient ID (including
network package data). A prompt is displayed when the data is deleted. A prompt of It is
successful to delete the data is displayed after the data is successfully deleted. The patient ID
saving data cant be deleted.
n Removing USB storage device
It is used to remove USB. Press this button before unplugging the USB storage device. If the data
is being saved when you press the button, a prompt of Data is transmitting, please waiting will
display. If data is successfully deleted, a prompt of It is successful to delete will display.
Unplug the USB storage device after successful deletion.
Note: The USB storage device may be damaged or patient monitoring data may be
lost if you dont follow those steps and unplug the USB storage device directly.
- 33 -
3 Installation of Monitor
NOTE:
To ensure that the monitor works properly, please read user manual and service manual
carefully, and follow the steps before using the monitor.
Make sure the AC power supply complies with the following specifications: 100~240 VAC,
50/60 Hz.
Apply the power line provided with the monitor. Plug the power line to INPUT interface of
the monitor. Connect the other end of the power line to a grounded 3-phase power output.
NOTE:
Connect the power line to the jack special for hospital usage.
n
NOTE:
When the battery configuration is provided, after the device is transported or stored, the
battery must be charged. Switching on AC power supply can charge the battery no
matter if the monitor is powered on.
- 34 -
- 35 -
Figure 3-1
Figure 3-2
Figure 3-3
Installation Steps:
1. Use part 1 to draw lines on the wall at the desired location.
2. Drill four holes of 6mm in diameter in the wall, and then knock the plastic nuts into the
- 36 -
holes completely.
3. Knock four screws in the plastic nuts, when tightened; secure the channel (part1) at the
desired location of the wall (as shown in Figure 3-1).
4. Slide the arm (part2) into channel (part1) as Figure 3-2 shows to the desired location.
5. Tighten the manual screw and secure the arm (part2) at the desired position within the
channel (part1).
6. Face the side with duplexing piece of the device holding plate to the underside of the
patient monitor, fix it with M425mm screw (as shown in Figure 3-3).
7. Pull out the fixing screw from the fixing hole.
8. At the same time, put the arm (part2) into the patient monitor with the device holding
plate, and secure the fixing screw totally through the fixing hole.
9. The patient monitor can be adjusted by a maximum 15 degrees by rotating the black
knob.
NOTE:
1. When using the monitor and other medical devices at the same time, requirements
regarding power distribution of medical equipment must be abided by for fear that the
leakage currents of devices overlap and consequently injury the patient or the medical
personnel.
2. Do not use the monitor in the presence of flammable anesthetics to avoid the hazard
of explosion.
- 37 -
Routine Check
The overall check of the monitor, including the functional safety check, must be performed by
qualified personnel every 6 to 12 months or each time after repair of the monitor. All checks that
need to open the monitor enclosure must be performed by qualified service personnel.
WARNING
If the hospital or agency does not follow a satisfactory maintenance schedule when
using monitor, the monitor may become invalid, and the human health may be
endangered.
4. Make sure the air way is sealed well, the pneumatic value is less than 3mmHg/min. Fill the
system with gas, observe real-time pressure value and displayed pressure value in
Thermometer.
If the two values are equal, we can consider the NIBP measurement of the monitor has no failure.
T-connector
Thermometer
Monitor
Power
Charge
- 39 -
Main
Freeze
Silence
Record
Start
Menu
Pow er
Main
Freeze
Silence
Record
St art
Men u
Charge
1: Normal Saline with Heparin; 2: Distal end to patient; 3: 3-way stopcok; 4: Pressure transducer
interface cable; 5: Monitor; 6: Pressure transducer.
Figure 4-3 IBP Monitoring
- 40 -
1
6
Power
Main
Freeze
Silence
Record
Start
Menu
Charge
Calibration:
If you want to use the CPT CO2 module, connect as the following figure shows:
Hose
Monitor
To the air
Sample line
Water trap
T-connector
Gas
bottle
Fill the CO2 concentration in the item Concentration (unit: %), then perform the calibration.
NOTE
If you use C5 CO2 module and LoFlo CO2 module, the CO2 check>> item is unavailable.
Zero Calibration
The Zero calibration is intended to decrease the effect caused by baseline drifting. When you
perform calibration, the item ZERO CAL in CO2 setup menu is unavailable. After the Zero
calibration is finished successfully, the item is reactive. It is recommended that user should do the
Zero Calibration before Calibration.
NOTE
CPT CO2 module, C5 CO2 module and LoFlo CO2 module need to perform Zero
Calibration.
Pick the hot key CO2 on the screen to access the CO2 SETUP menu, select OTHER SETUP.
Then the following menu will pop-up:
- 42 -
- 43 -
Fill the concentration of calibrating gas in the right blank, compare it with the measured
concentration. If the two values have discrepancy, select CALIBRATION to calibrate.
If the two values are equal, select CONFIRM to exit the menu.
NOTE:
1. Make sure the discrepancy of calibrating gas is less than 1
2. The gas flux should be set in the range of 1050ml/min
3. The calibrating anesthetic gas concentration should be higher than 1.5%, CO 2 is
higher than 1.5%, N2O is higher than 40, O2 is higher than 40
4. Set up menu according to the 02 module or 03 module;
5. The discrepancy between calibrated value and measured value is less than 15.
NOTE:
The calibration should be done before high concentration O2 measurement.
- 44 -
1: 12.1 M9 LCD; 2: M9 front shuck assembly; 3: LCD assembly; 4: Main bracket assembly; 5: Sensor
module assembly; 6: M9 battery compartment cover; 7: Rear shuck assembly; 8: Cross recessed pan
head self-tapping screw ST312; 9: M9 label; 10: M9 cuff bracket; 11: Cross recessed pan head
screw M38; 12: Recorder; 13: M9 recorder slot cover; 14: Cross recessed pan head coil spring
screw M410; 15: Cross recessed pan head coil spring screw M310; 16: Cross recessed pan head
self-tapping screw ST38; 17: Plain washer 3.5; 18: Cross recessed pan head coil spring screw
M36.
Figure 5-1 M9 Series Disassembly Graphics
- 45 -
1: M9B 10.4 LCD; 2: M9B 12.1 front shuck assembly; 3: M8 12.1 front shuck assembly; 4: Cross
recessed pan head coil spring screw M36; 5: M8 series main bracket assembly; 6: M9B battery
compartment cover; 7: Sensor module assembly; 8: Rear shuck assembly; 9: Cross recessed pan
head self-tapping screw ST312; 10: M9B general label; 11: M9B recorder slot cover; 12: Recorder;
13: Cross recessed pan head coil spring screw M410; 14: Cross recessed pan head coil spring
screw M310; 15: Cross recessed pan head self-tapping screw ST38; 16: Plain washer 3.5.
Figure 5-2 M8 Series Disassembly Graphics
1-8: Function button; 9: Front shuck; 10: Connector for front shuck and rear shuck; 11: M9 shuttle
PCBA12: M9 keyboard PCBA; 13: Cross recessed pan head self-tapping screw; 14: Sponge pad,
Breadthwise; 15: Sponge pad, lengthways; 16: M9 alarm light board PCBA; 17: M9 alarm lampshade.
Figure 5-3 M9 Series Monitor Front Shuck Assembly
- 46 -
1: 12.1 inches screen lampshade; 2: Front shuck; 3: Power supply switch; 4-10: Function button; 11:
Connector for front shuck and rear shuck; 12: Sponge pad, breadthwise; 13: Sponge pad, lengthways;
14: Narrow keyboard PCBA.
Figure 5-4 M8 Series Monitor Front Shuck Assembly
1: SONATINA Rubber feet; 2: Fan; 3: Nut M34: SONATINA Fan bracket; 5: Cross recessed pan
head self-tapping screw ST38; 6: Cross recessed countersunk head screw M323; 7: M9D Speaker
bracket; 8: Moving speaker; 9: M9 Rear shuck; 10: M9 handle cover; 11: Cross recessed pan head
self-tapping screw ST312; 12: M9 handle top cover; 13: Cross recessed pan head screw M38; 14:
M9 handle bottom cover; 15: M9 rear shuck/add GAS seat slot; 16: GAS seat fixed sheet; 17: GAS
seat; 18: Cross recessed pan head screw M38.
Figure 5-5 M9 Series Monitor Rear Shuck Assembly
- 47 -
1: SONATINA Rubber feet; 2: Fan; 3: Nut M34: SONATINA Fan bracket; 5: Cross recessed pan
head self-tapping screw ST38; 6: Cross recessed countersunk head screw M323; 7: M9D Speaker
bracket; 8: Moving speaker; 9: M9B Rear shuck; 10: SONATINA handle; 11: SONATINA top cover; 12:
Cross recessed pan head self-tapping screw ST312; 13: CO2 functional rear shuck (with recorder);
14: CO2 water trap.
Figure 5-6 M8 Series Monitor Rear Shuck Assembly
- 48 -
- 49 -
1: M9 series main bracket; 2: Cross recessed pan head screw M2.56; 3: SONATINA(B) Valve; 4:
SONATINA(B) air pump; 5: BM100 insulated gasket; 6: BM100 monitor module/with CE; 7: Cross
recessed pan head screw M36; 8: Cross recessed pan head coil spring screw M36; 9: M9 battery
baffle; 10: Ni-H battery; 11: SONATINA(B) battery spring; 12: Nut M3; 13: SONATINA(B) battery
board PCBA; 14: Cross recessed pan head coil spring screw M35; 15: M9 battery compartment; 16:
Copper stud H4.75*13+3 (M3); 17: V6 module; 18: 2410 main board; 19: Cross recessed
countersunk head screw M36; 20: M9 build-in recorder bracket; 21: M9 rear board; 22: Hexagon
nut M6; 23: Plain washer 6; 24: M9B network board PCBA; 25: Grounding wire pole; 26: M9 label on
rear board; 27: Copper stud H4.75*8+3 (M3); 28: CO2 module setting board; 29: Plain washer 3.5;
30: CO2 module; 31: CO/IBP module; 32: Artema GAS module interface PCBA; 33: GAS module
fixed board; 34: GAS module; 35: COIBP side fixed bracket; 36: SpO2 module A6; 37: SpO2 module
MP506; 38: SpO2 module MR9006; 39: CADENCE fuse seat connecting line component/blue; 40:
CADENCE fuse seat connecting line component/brown; 41: Power supply socket; 42: M9B Fuse seat
gasket; 43: M9 power supply rear board; 44: Power supply bracket; 45: Industrial control main
board(with sound card)/EW-AM 3902B0 version; 46: M9 rear shuck interface PCBA/without 485
network, with LVDS.
Figure 5-9 M9 Series Monitor Main Bracket Disassembly, Exploded
- 50 -
1: M8 series main bracket; 2: Cross recessed pan head screw M2.56; 3: SONATINA(B) Valve; 4:
SONATINA(B) air pump; 5: BM100 insulated gasket; 6: BM100 monitor module/with CE; 7: Cross
recessed pan head screw M36; 8: Cross recessed pan head coil spring screw M36; 9:
SONATINA(B) battery fastener; 10: Ni-H battery; 11: SONATINA(B) battery spring; 12: Nut M3;
13: SONATINA(B) battery board PCBA; 14: Cross recessed pan head coil spring screw M35; 15:
M9B battery compartment (12.1 LCD); 16: Copper stud H4.75*13+3 (M3); 17: V6 module; 18: 2410
main board; 19: Cross recessed countersunk head screw M36; 20: M9 build-in recorder bracket; 21:
M9 rear board; 22: Hexagon nut M6; 23: Plain washer 6; 24: M9B network board PCBA; 25:
Grounding wire pole; 26: M9 label on rear board; 27: Copper stud H4.75*8+3 (M3); 28: CO2 module
setting board; 29: Plain washer 3.5; 30: CO2 module; 31: CO/IBP module; 32: SpO2 module A6; 33:
SpO2 module MP506; 34: SpO2 module MR9006; 39: CADENCE fuse seat connecting line
component/blue; 40: CADENCE fuse seat connecting line component/brown; 41: Power supply
socket; 42: M9D Fuse seat gasket; 43: M9 power supply rear board; 44: Power supply bracket; 45:
Industrial control main board(with sound card)/EW-AM 3902B0 version; 46: M9 round rear shuck
interface PCBA/without 485 network, with LVDS.
Figure 5-10 M8 Series Monitor Main Bracket Disassembly Graphics, Exploded
- 51 -
1: 12.1 inches LCD screen; 2: M9 screen bracket; 3: SONATINA(B) LCD screen power switch
board; 4: Cross recessed pan head screw M36; 5: Cross recessed pan head coil spring screw
M36.
Figure 5-11 M9 Series Monitor TFT Assembly
1: Cross recessed pan head screw M36; 2: 12.1 inches TFT LCD screen G121SN01; 3: M8 12.1
LCD bracket; 4: Power switch board 0426-K.
Figure 5-12 M8 Series Monitor TFT Assembly
- 52 -
1: Digital SpO2 sensor socket connecting wire; 2: M9 sensor label; 3: M9 sensor outer board; 4: M9
TEMP seat gasket; 5: Cross recessed pan head screw M36; 6: BM100 monitor module TEMP
socket connecting wire; 7: CO2 link board; 8: M9 sensor inner board; 9: BM100 monitor module ECG
socket connecting wire; 10: Cross recessed pan head screw M2.56; 11: SONATINA NIBP socket; 12:
M9B NIBP sensor gasket; 13: CO2 cannula air outlet.
Figure 5-13 M9 Series Monitor Sensor Bracket Assembly
- 53 -
1: Digital SpO2 sensor socket connecting wire; 2: M9 sensor label; 3: M9 sensor outer board; 4: M9
TEMP seat gasket; 5: Cross recessed pan head screw M36; 6: BM100 monitor module TEMP
socket connecting wire; 7: CO2 link board; 8: M9 sensor inner board; 9: BM100 monitor module ECG
socket connecting wire; 10: Cross recessed pan head screw M2.56; 11: SONATINA NIBP socket; 12:
M9B NIBP sensor gasket; 13: CO2 cannula air outlet.
Figure 5-14 M8 Series Monitor Sensor Bracket Assembly
- 54 -
6 Troubleshooting
In transportation, storage and usage of patient monitor, various factors such as unstable network
voltage, changing environmental temperature, falling-down or impact, component aging may all
result in patient monitor failures and therefore affect normal application of the device. In failure
conditions, professional personnel with the experience of repairing electronic medical devices
should perform component-level upkeep as per the failure classification listed in the table below.
Component-level upkeep means based on analyzing, replacing or trial-operating the component,
we can pinpoint the failure on a certain component of the device, such as power board, main
board, TFT assembly, measuring cable or parameter module, etc. Repair of only some
components means component-level repair. The repair must be conducted by a service engineer
with abundant experience and with the assistance of special equipment and in specific
environments and conditions.
Possible cause
Solution
Replace fuse
Power damage
Component
short-circuit
No
display
after
power-on
or
black
screen during operation,
however,
power
indicator lights and the
fan runs normally.
Data communication
error between Main
board and parameter
module
Operation
or
measurement function is
disabled.
Main board
corresponding
component damage
or
Device is occasionally
intensive
No
display
after
power-on,
power
indicator is not on or fan
does not run.
Moment
- 55 -
stoned.
interference of network
grounding system
Poor performance of
power board
Poor performance of
Main board
Bad connection of
power supply or main
board
Replace
connectors
or
repair
Possible cause
Power
damage
switch
Solution
board
Repair
or
connecting wire
replace
Possible cause
Solution
or
- 56 -
bed
Possible cause
Solution
Replace
supply
power
Possible cause
- 57 -
Solution
Connect RL electrode
ECG waveform is
abnormal
or
has AC power
interference
grounding wire
Patient
constantly
is
No RESP waveform or
RESP waveform is closed
RESP waveform is
abnormal
RESP wave amplitude is
weak
HR
value
is ECG waveform is not Adjust the connection to
inaccurate, Arr. and ST good
make the ECG waveform normal
analysis are incorrect.
NIBP cuff can not be Air way is folded or has Adjust or repair the air way
inflated.
leakage
- 58 -
Blood pressure can not Cuff becomes loose or Keep the patient quiet, bind
be
measured patient is moving
the cuff correctly and safely
occasionally.
Cuff size does not fit the Use the cuff of appropriate
Error
of
blood patient
size
pressure measurement
NIBP module has bad Replace NIBP module
is too great.
performance
No SpO2 waveform
Patient is moving
Keep the patient quiet
SpO2 waveform has
Environment light is very Weaken the light intensity in
strong interference.
intensive
the environment
SpO2
value
inaccurate
No CO2 waveform
CO2 module
The CO2 waveform is The CO2 module is in Change the STANDBY mode
a beeline
STANDBY mode
to MEASURE mode
The sample line is blocked Draw off the sample line,
or disconnected
clear it or replace it to another
one.
The CO2 waveform is Long time no zero Enter the CO2 SETUP, do
abnormal, values are calibration, the measured CO2 calibration by ZERO CAL
incorrect
values are incorrect
The measured CO2 The CO2 module is in Change the STANDBY mode
values are displayed as STANDBY mode
to MEASURE mode
---
Prompts
for
CO2 The CO2 sample line is Draw off the CO2 sample line,
catheter is blocked on blocked
clear it or replace it to another
screen
one.
The CO2 measured Long time
value has error
calibration, the
value is incorrect
- 59 -
GAS module
GAS
measured
value is incorrect
- 60 -
1)
2)
3)
4)
5)
CAUTION
Follow the manufacturers instruction to dilute the solution, or adopt the lowest
possible density.
Do not let liquid enter the monitor.
No part of this monitor can be subjected to immersion in liquid.
Do not pour liquid onto the monitor during sterilization.
Use a moistened cloth to wipe off any agent remained on the monitor.
CAUTION
Do not use EtO gas or formaldehyde to disinfect the monitor.
The monitor must be kept away from dust-free.
It is recommended that you should clean the outside surface of the monitor enclosure and the
display screen regularly. Only use non-caustic detergents such as soap and water to clean the
monitor enclosure.
b.
c.
d.
e.
Sterilization
To avoid extended damage to the equipment, sterilization is only recommended when stipulated
as necessary in the Hospital Maintenance Schedule. Sterilization facilities should be cleaned first.
Recommended sterilization material:
1 Ethylate: 70% alcohol, 70% isopropanol
2 Acetaldehyde
Disinfection
To avoid extended damage to the equipment, disinfection is only recommended when stipulated
as necessary in the Hospital Maintenance Schedule. Disinfection facilities should be cleaned first.
WARNING
Do not squeeze the rubber tube on the cuff.
Do not allow liquid to enter the connector socket at the front of the monitor.
Do not wipe the inner part of the connector socket when cleaning the monitor.
When the reusable cuff is not connected to the monitor, or being cleaned, always
place the cover on the rubber tube to avoid liquid permeation.
- 62 -
To replace the rubber bag in the cuff, first place the bag on top of the cuff so that the rubber tubes
line up with the large opening on the long side of the cuff. Now roll the bag lengthwise and insert
it into the opening on the long side of the cuff. Hold the tubes and the cuff and shake the
complete cuff until the bag is in position. Thread the rubber tubes from inside the cuff, and out
through the small hole under the internal flap.
Wescodyne
Cidex
Lysol
Vesphene
Do not immerse the connector in any liquid. After cleaning, dry the transducer thoroughly before
storing. Slight discoloration or temporary increase of surface stickiness of the cable should not be
considered abnormal if adhesive tape residue must be removed from the transducer cable. Double
seal tape remover is effective and will cause a minimum of damage to the cable if used sparingly.
Acetone, Alcohol, Ammonia and Chloroform, or other strong solvents are not recommended
because over time the vinyl cabling will be damaged by these agents.
NOTE:
The disposable transducers or domes must not be re-sterilized or re-used.
NOTE:
For protecting environment, the disposable transducers or domes must be recycled or
disposed of properly.
Sterilization
Liquid Chemical Sterilization
Remove obvious contamination by using the cleaning procedure described previously. Select
a sterilant that your hospital or institution has found to be effective for liquid chemical
sterilization of operating room equipment. Buffered gluteraldehyed (e.g. Cidex or Hospisept)
has been found to be effective. Do not use quaternary cationic detergents such as zephiran
chloride. If the whole unit is to be sterilized, immerse the transducer but not the electrical
connector into the sterilant for the recommended sterilizing period. Be sure that the dome is
removed. Then rinse all transducer parts except the electrical connector with sterilized water
or saline. The transducer must be thoroughly dried before storing.
Gas Sterilization
For more complete asepsis, use gas sterilization.
Remove obvious contamination by using the cleaning procedure described previously. To
inhibit the formation of ethylene glycol when ethylene oxide gas is used as the disinfectant,
the transducer should be completely dry.
Follow the operating instructions provided by the manufacturer of the gas disinfectant.
WARNING
The sterilization temperature must not exceed 70C (158F). Plastics in the pressure
transducer may deform or melt above this temperature.
The TEMP probe should not be heated above 100C (212). It should only be subjected
briefly to temperatures between 80 (176) and 100C (212).
The probe must not be sterilized in steam.
Only detergents containing no alcohol can be used for disinfection.
The rectal probes should be used, if possible, in conjunction with a protective rubber cover.
To clean the probe, hold the tip with one hand and with the other hand rubbing the probe
down in the direction of the connector using a moist lint-free cloth.
NOTE:
Wash the probe with clean water after disinfecting and sterilizing to remove any
remaining solution. The probe can only be reused after being dried thoroughly.
NOTE:
Do not disinfect the probe by means of water boiled.
NOTE:
The product has not been disinfected at the factory.
NOTE:
Any residue should be removed from the probe before being disinfected and sterilized,
and avoid contacting corrosive solvent. Dipping the cable into alcohol or alkalescent
solvent for a long time, may reduce the flexibility of the scarfskin of the cable. Also, the
connector should not be dipped.
NOTE:
After monitoring, disinfect the probe according to the instruction described in the service
manual and user manual.
NOTE:
Disposable TEMP probe must not be re-sterilized or reused.
NOTE:
Cavity temperature probe is only suggested to be used inside the recta. We recommend
that you use the disposable cannula to prevent cross infection.
NOTE:
For protecting environment, the disposable TEMP probe must be recycled or disposed of
properly.
NOTE:
Do not force the cavity temperature probe against resistance when inserted into human
body. Also it is not recommended to use it in bleeding part and cankerous part of human
- 65 -
body.
For cleaning:
n
Use a cotton ball or a soft mull moistened with hospital-grade ethanol to wipe the surface of
the sensor, and then dry it with a cloth. This cleaning method can also be applied to the
luminotron and receiving unit.
The cable can be cleaned with 3% hydrogen dioxide, 7% isopropanol, or other active
reagents. However, connector of the sensor shall not be subjected to such solution.
n Bacteria filter
The bacteria filter is one-off type, i.e., one bacteria filter can only be used on one patient.
n Sample line
The sample line is one-off type.
not immerse the tube into the liquid. After cleaning, use wet cloth to wipe off the disinfector
and then use dry cloth to wipe the tube.
n Occlusion handling
If the GAS module passage is occluded, the screen will display the message AG
OCCLUSION. The following are a few examples of occlusion, which you may remove one
by one until this message disappears.
Entrance Occlusion
If the part at the entrance such as filter, sample line or airway connector is occluded by
condensed water, the screen will display the message telling that the airway is occluded.
The optimal method to remove clogs of this kind is:
Check for clogs in entrance parts:
a. Replace the bacteria filter at the entrance.
b. Check the sample pipe for clogs and/or entangle. If necessary, replace it.
c. Check the airway connector for water. If necessary, drain off the water and install the
connector again.
Internal Occlusion
If the interior of the GAS Module is contaminated by condensed water, the screen will also
display the message telling that the airway is occluded.
The optional method to remove clogs of this kind is:
Step 1: as usual, check the entrance or the exit for clogs and remove them.
Step 2: if occlusion still persist after step 1, you should consider the existence of interior
occlusion. In this situation, contact the manufacturer.
- 68 -
User Maintainance
Input the password into the ENTER MAINTAIN PASSWORD box and press CONFIRM,
the USER MAINTAIN menu will pop up, in which you can set up following items.
Factory Maintain
Factory maintenance function is only available for the service engineers of EDAN or
representatives authorized by EDAN.
1. Enter factory maintain through password.
- 69 -
- 70 -
- 71 -
Accessories
M15-40000
M15-40010
M15-40060
M15-40094
M15-40046
M15-40028
M15-40090
M15-40024
M15-040155
M15-40109
MS3-109069
M15-40099
M15-40125
M13-36091
MS2-30043
M15-40096
M15-40107
M15-40108
MS1-30131
M15-40029
M15-40074
M15-40043
M15-40018
Child Cuff
M15-40020
M15-40097
M15-40098
M13-36036
MS1-30437
M15-40007
MS0-18927
M13-36087
M15-40121
MS1-100174
M15-40119
M15-40120
MS1-100175
M50-78085
M50-78084
M50-78083
MS1-100214
(18-26cm)
- 73 -
MS1-100216
MS1-100217
MS1-100218
M12-031446
M12-031447
M15-040138
MS3-30164
Mounting system
M21-064089
(14.8V, 2Ah)
M21-64044
(14.8V, 4Ah)
MS9-100403
Rolling Stand
- 74 -
EDAN on time. We will, at this option, dispatch the replace one(s) with confirmed shipping
invoice.
NOTE:
(1) Both Return Material Authorization Form and Declaration Form are offered
by EDAN service department once the SCF is confirmed by service
engineer.
(2) Customer is responsible for freight & insurance charges when the
equipment is shipped to EDAN for service including custom charges. EDAN
is responsible for the freight, insurance & custom charges from EDAN to
customer.
Out of Warranty:
After receiving the RMA from service department, customer sends defective parts to EDAN
in advance. We will analyze the problems and discuss with customer about either repairing or
replacing the part(s). Once the maintenance fee is invoiced and paid, we will make sure to
dispatch good part(s) to confirmed address.
NOTE: Customer is responsible for any freight & insurance charge for the
returned product.
(3) Obtain RMA Form.
Before the shipment of the materials, customer must obtain a RMA form from our service
department, in which the RMA number, description of returning parts and shipping
instruction are included. The RMA number should be indicated on the outside of the shipping
container.
NOTE: EDAN should not have any obligation to end-user or customer who
returns the goods without the notification by EDANs service department. The
sender takes the whole responsibility of accounted fee.
Disassemble the parts with anti-static facility. Do not touch the parts with naked hand.
Pack the parts safely before returning.
Put the RMA number on the parcel.
Describe the returned parts. The total value on the invoice should be less than USD100, and
note on the invoice as sample, no commercial value.
Confirm the invoice with EDAN before shipment.
Send back the parts after EDANs confirmation.
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Contact Information
If you have any question about maintenance, technical specifications or malfunctions of devices,
do not hesitate to contact us.
EDAN Instruments, Inc.
TEL: +86-755-26898321, 26899221
FAX: +86-755-26882223, 26898330
E-mail: support@edan.com.cn
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EMC type
Anti-electroshock degree
Class A
ECG (RESP), TEMP, IBP, CO
CF
SpO2, NIBP, CO2, GAS
BF
IPX1
Refer to Chapter 12~Chapter 19 for details.
Continuous running equipment
Ingress Protection
Disinfection/sterilizing method
Working system
A1.2 Specifications
A1.2.1 Size and Weight
Weight
5 kg
A1.2.2 Environment
Temperature
Working
5 ~ 40 C
-20 ~ 55 C
Humidity
Working
25% ~ 80 %
Altitude
Working
Transport and Storage
Power Supply
860hPa ~ 1060hPa
700hPa ~ 1060hPa
100/240 VAC, 50/60 Hz,
Pmax=80VA FUSE T 1.6AL
A1.2.3 Display
Display screen
10.4/12.1 inch, Multicolour TFT LCD,
Resolution 800600, 1 LED
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Messages
11 Waveforms Maximum
1 Power LED (Green)
1 Alarm LED (Yellow/Red)
1 Charge LED (Yellow)
3 Sound Mode corresponding Alarm Mode
A1.2.4 Battery
Quantity
Type
Power-off delay
Voltage
Capacitance
Working period
Rechargeable period
1
Li battery
5 ~ 15min
14.8 VDC
2 Ah, 4Ah (optional)
2Ah
80min
4Ah
180min
(At 25, continuous SpO2 measuring mode and NIBP
automatic measuring mode)
2Ah
150min
4Ah
360min
(Monitor is turned on or in Standby mode.)
48 mm
25mm/S, 50mm/S
3
Continuous real-time recording
8 second real-time recording
Auto 8 second recording
Parameter alarm recording
Drug Calculation and titration table recording
A1.2.6 Recall
Trend Recall
Short
Long
NIBP Measurement Recall
A1.2.7 ECG
Lead Mode
4 selectable plus:
Lead selection
Waveform
PACE detection
Detection leads
Can detect impulse as follows:
Pulse amplitude
Pulse width
2 ~ 700mV
0.1 ~ 2.0 ms
Ascending time
<5000V
<360J
<5s
<10%
< 100 C
<10s
Rate0.25
Input voltage range
CMRR
Diagnosis
Monitor
Surgery
Frequency response
Diagnosis
Monitor
Surgery
System noise
HR Measuring and Alarm Range
Adu/Ped
Neo
Accuracy
Resolution
Sensitivity
Differential Input Impedance
300mVd.c.
< 10 uA
Monitor
Surgery
Diagnosis
600mVd.c.
-2.0 ~ +2.0 mV
A1.2.8 RESP
Method
Base line Impedance Range
Measuring Sensitivity
Noise
Max. dynamic range
Waveform bandwidth
0.2Hz ~ 2.5Hz-3dB
Clampe time
Resume time
0 rpm ~120rpm
0 rpm ~150rpm
1 rpm
Accuracy
2 rpm
Gain Selection
0.25, 0.5, 1, 2, 3, 4, 5
A1.2.9 NIBP
Method
Mode
Measuring Interval in AUTO Mode
Continuous
Measuring Type
Measuring Rang
Adult Mode
SYS
DIA
MAP
Pediatric Mode
SYS
DIA
MAP
Neonatal Mode
SYS
DIA
MAP
Cuff Pressure measurement range
Pressure Resolution
Mean error
Maximum Standard deviation
Auto cuff inflation
Typical Measurement Period
Overvoltage protection
Adult
Pediatric
Oscillometric
Manual, Auto, Continuous
1/2/3/4/5/10/15/30/60/90/120/240/480 Min
5min, interval is 5s
Systolic Pressure, Diastolic Pressure, Mean Pressure
40~270mmHg
10~215mmHg
20~235mmHg
40~200mmHg
10~150mmHg
20~165mmHg
40~135mmHg
10~100mmHg
20~110mmHg
0~290mmHg
1mmHg
5mmHg
8mmHg
Adult/Pediatric 120s
Neonate
90s
30~45s (depend on HR/motion disturbance)
Dual Overvoltage protection
2973mmHg
2403mmHg
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Neonatal
PR
Measurement range
Resolution
Accuracy
1453mmHg
40~240bpm
1 bpm
3bpm or 3.5% (the larger)
A1.2.10 SpO2
Measuring Range
Alarm Range
Resolution
Accuracy
0 ~ 100 %
0 ~ 100 %
1%
2 digits70%~100% SpO2
Undefined0~70% SpO2
Neonate
3 digits70%~100% SpO2
Undefined0~70% SpO2
Pulse Rate
Measuring and Alarm Range
Resolution
30 ~ 254 bpm
1 bpm
Accuracy
3bpm
Under Motion Condition, 5 bpm
1 ~ 100 %
1 ~ 100 %
1%
2 digits70%~100% SpO2
Undefined0~70% SpO2
Neonate
3 digits70%~100% SpO2
Undefined0~70% SpO2
Pulse Rate
Measuring and Alarm Range
Resolution
20~250bpm
1bpm
Accuracy
3 bpm
Low Perfusion
0.03 % ~ 20 %
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A1.2.11 TEMP
Channel
Measuring Range
0 ~ 50 C
Sensor type
Resolution
0.1C
Accuracy
0.1C (25 ~ 45 C)
0.2C (0 ~ 25C4550C )
Refresh Time
Selftest
Data sample
Every 1 ~ 2 seconds
Every about 5 ~ 10 minutes
50Hz, 12 bits
A1.2.12 IBP
Channel
Label
Pressure Sensor
Sensitivity
Impedance
2
ART, PA, CVP, RAP, LAP, ICP, P1, P2
5 (V/V/mmHg)
300 ~ 10, 000 (Ohm)
Frequency Response
Measuring and Alarm Range
ART
PA
CVP/RAP/LAP/ICP
P1/P2
Resolution
Zero range
200 mmHg
A1.2.13 CO2
Method
Measuring mode
Measuring range
CO2
AwRR
Resolution
CO2
InsCO2
AwRR
Accuracy
1 mmHg
1mmHg
1 rpm
CO2
2 mmHg, 0 ~ 40 mmHg
Reading 5%, 41 ~ 70 mmHg
Reading 8%, 71 ~ 100 mmHg
Reading 10%, 101 ~ 150 mmHg
AwRR
Suffocation Alarm Delay
AwRR
Response time
Calculation Method
Stability
Short Term Drift
Long Term Drift
O2 Compensation
Range
Resolution
Default
1 rpm
10 ~ 40 seconds
<3 seconds, includes transport time, risetime
BTPS (Body Temperature Pressure Saturated)
Drift over four hours < 0.8 mmHg
120 hour period
0 to 100%
1%
16%
A1.2.14 CO
Method
Measuring range
CO
Thermodilution Technique
0.1 ~ 20L/min
TB
23 ~ 43C
TI
-1 ~ 27C
Resolution
CO
0.1L/min
TB, TI
0.1C
Accuracy
CO
5% or 0.2 L/min
TB
0.1C
TI
0.1C
Output parameters
CO
Hemodynamic Calculation
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Alarm range
23 ~ 43C
A1.2.15 GAS
Technology
Measuring range
CO2
0 ~ 10
O2
0 ~ 100
N2O
0 ~ 100
AwRR
2 ~ 100 rmp
Halothame
0 ~ 5
Isoflurane
0 ~ 5
Enflurane
0 ~ 5
Sevoflurane
0 ~ 8
Desflurane
0 ~ 18
Gas
CO2
Concentration[%REL]
Inaccuracy [%ABS]
0-1
0.1
1-5
0.2
5-7
0.3
7-10
0.5
>10
Unspecified
0-20
20-100
0-25
25-80
80-100
HAL, ENF,
0-1
0.15
ISO
1-5
0.2
N2O
O2
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>5
Unspecified
0-1
0.15
1-5
0.2
5-8
0.4
>8
Unspecified
0-1
0.15
1-5
0.2
5-10
0.4
10-15
0.6
15-18
>18
Unspecified
SEV
DES
Updating frequency
Calibrate
GAS calibrate stability
Descending time
Delay time
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