Manual de Servicio Mec2000

MEC-2000 Patient Monitor
Service Manual
Copyright
Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called

Mindray) owns all rights to this unpublished work and intends to maintain this work
as
confidential. Mindray may also seek to maintain this work as an unpublished
copyright. This
publication is to be used solely for the purposes of reference, operation,
maintenance, or
repair of Mindray equipment. No part of this can be disseminated for other
purposes.
In the event of inadvertent or deliberate publication, Mindray intends to enforce

its rights to
this work under copyright laws as a published work. Those having access to this
work may
not copy, use, or disclose the information in this work unless expressly authorized
by
Mindray to do so.
All information contained in this publication is believed to be correct. Mindray

shall not be
liable for errors contained herein nor for incidental or consequential damages in
connection
with the furnishing, performance, or use of this material. This publication may
refer to
information and protected by copyrights or patents and does not convey any license
under the
patent rights of Mindray, nor the rights of others. Mindray does not assume any
liability
arising out of any infringements of patents or other rights of third parties.
Content of this manual is subject to changes without prior notice.
PROPERTY OF SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

ALL RIGHTS RESERVED
Responsibility on the manufacturer party
Mindray 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 Mindray qualified personnel;
�
applied electrical appliance is in compliance with relevant National Standards;
�
the monitor is operated under strict observance of this manual.
I
For continued safe use of this equipment, it is necessary that the listed
instructions are
followed. However, instructions listed in this manual in no way supersede
established
medical practices concerning patient care.
WARNING
�
Do not rely only on audible alarm system to monitor patient. When monitoring
adjusting the volume to very low or completely muting the sound may result in
the disaster to the patient. The most reliable way of monitoring the patient is at
the same time of using monitoring equipment correctly, manual monitoring
should be carried out.
�
This multi-parameter patient monitor is intended for use only by medical
professionals in health care institutions.
�
To avoid electrical shock, you shall not open any cover by yourself. Service must
be carried out by qualified personnel.
�
Use of this device may affect ultrasonic imaging system in the presence of the
interfering signal on the screen of ultrasonic imaging system. Keep the distance
between the monitor and the ultrasonic imaging system as far as possible.
�
It is dangerous to expose electrical contact or applicant coupler to normal saline,
other liquid or conductive adhesive. Electrical contact and coupler such as cable
connector, power supply and parameter module socket-inlet and frame must be
kept clean and dry. Once being polluted by liquid, they must be thoroughly
dried. If to further remove the pollution, please contact your biomedical
department or Mindray.
It is important for the hospital or organization that employs this equipment to
carry out a
reasonable maintenance schedule. Neglect of this may result in machine breakdown or
injury
of human health.
Revision History
This manual has a revision number. This revision number changes whenever the manual
is
updated due to software or technical specification change. Contents of this manual
are subject
to change without prior notice.
�
Revision number: 1.0
�
Release time: 2009-02
� 2009 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved.
II
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANT ABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any
transportation or
other charges or liability for direct, indirect or consequential damages or delay
resulting from
the improper use or application of the product or the substitution upon it of parts
or
accessories not approved by Mindray or repaired by anyone other than a Mindray
authorized
representative.
This warranty shall not extend to any instrument which has been subjected to
misuse,
negligence or accident; any instrument from which Mindray's original serial number
tag or
product identification markings have been altered or removed, or any product of any
other
manufacturer.
Safety, Reliability and Performance
Mindray is not responsible for the effects on safety, reliability and performance
of the
MEC-2000 Patient Monitor if:
�
assembly operations, extensions, re-adjusts, modifications or repairs are carried
out by
persons other than those authorized by Mindray.
�
the MEC-2000 is not used in accordance with the instructions for use, or the
electrical
installation of the relevant room does not comply with NFPA 70: National Electric
Code
or NFPA 99: Standard for Health Care Facilities (Outside the United States, the
relevant
room must comply with all electrical installation regulations mandated by the local
and
regional bodies of government).
III
Return Policy
Return Procedure
In the event that it becomes necessary to return a unit to Mindray, the following
procedure
should be followed:
1.
Obtain return authorization. Contact the Mindray Service Department and obtain a
Customer Service Authorization (Mindray) number. The Mindray number must appear
on the outside of the shipping container. Return shipments will not be accepted if
the
Mindray number is not clearly visible. Please provide the model number, serial
number,
and a brief description of the reason for return.
2.
Freight policy. The customer is responsible for freight charges when equipment is
shipped to Mindray for service (this includes customs charges).
Company Contact
Manufacture: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial
Park, Nanshan, Shenzhen, P.R.China,518057
Phone: +86 755 26582479 26582888
Fax:
+86 755 26582500 26582501
IV
Contents
1
Safety.............................................................................
................................................... 1-1
1.1 Safety
Information .......................................................................
...................................1-1
1.1.1
DANGER ............................................................................
............................... 1-2
1.1.2
Warnings...........................................................................
.................................. 1-2
1.1.3
Cautions ..........................................................................
................................... 1-2
1.2 Equipment
Symbols ...........................................................................
............................. 1-3
2 About the
Product ...........................................................................
................................. 2-1
2.1
Introduction.......................................................................
............................................. 2-1
2.2
Application........................................................................
............................................. 2-1
2.2.1
General............................................................................
................................... 2-1
2.2.2
Usage..............................................................................
.................................... 2-2
3
Principles.........................................................................
................................................. 3-1
3.1
General............................................................................
............................................... 3-1
3.1.1 Parameter
Measurement........................................................................
............. 3-2
3.1.2 Main Control

Part...............................................................................
................ 3-2
3.1.3 Man-Machine
Interface..........................................................................
............ 3-2
3.1.4 Power
Supply ............................................................................
......................... 3-2
3.1.5 Other Auxiliary

Functions..........................................................................
........ 3-2
3.2 Hardware
Description .......................................................................
.............................. 3-3
3.2.1 Main
Board..............................................................................
........................... 3-4
3.2.2 ECG/RESP/TEMP
Module ............................................................................
.... 3-6
3.2.3 CO/IBP
Module.............................................................................
..................... 3-8
3.2.4 SpO2
Module ............................................................................
......................... 3-9
3.2.5 NIBP
Module ............................................................................
........................3-11
3.2.6 Recorder
Module.............................................................................
................. 3-12
3.2.7 Button
Panel..............................................................................
....................... 3-13
3.2.8 Power
PCB................................................................................
....................... 3-14
3.3 Software
Description........................................................................
............................. 3-16
3.3.1
General ...........................................................................
.................................. 3-16
3.3.2 System
Task...............................................................................
....................... 3-17
3.3.3 System
Function...........................................................................
.................... 3-18
3.4 System
Parameter..........................................................................
................................ 3-19
3.4.1
General............................................................................
................................. 3-19
3.4.2
ECG/RESP ..........................................................................
............................. 3-20
3.4.3
NIBP...............................................................................
.................................. 3-21
3.4.4
SpO2...............................................................................
.................................. 3-21
3.4.5
TEMP ..............................................................................
................................. 3-22
1
3.4.6
IBP ...............................................................................
.................................... 3-22
3.4.7
CO ................................................................................
.................................... 3-22
3.4.8
CO2 ...............................................................................
................................... 3-23
4 Product
Specifications ....................................................................
................................. 4-1
4.1 Safety
Classifications....................................................................
..................................4-1
4.2 Environmental
Specifications ....................................................................
..................... 4-1
4.3 Power Source

Specifications.....................................................................
...................... 4-2
4.4 Hardware
Specifications ....................................................................
............................. 4-2
4.5 Data
Storage............................................................................
........................................ 4-3
4.6 Signal Output

Specifications.....................................................................
...................... 4-4
4.7 ECG
Specifications ....................................................................
..................................... 4-5
4.8 RESP
Specifications.....................................................................
................................... 4-7
4.9 SpO2
Specifications.....................................................................
.................................... 4-8
4.10 NIBP
Specifications ....................................................................
.................................. 4-9
4.11 TEMP
Specifications.....................................................................
.............................. 4-10
4.12 IBP
Specifications.....................................................................
.................................. 4-10
4.13 CO
Specifications.....................................................................
....................................4-11
4.14 CO2
Specifications ....................................................................
...................................4-11
5 Disassembling/Assembling &
Troubleshooting.............................................................. 5-1
5.1 MEC-2000
Disassembling/Assembling ..........................................................
................ 5-1
5.1.1 Exploded View of MEC-

2000............................................................................ 5-
1
5.1.2 MEC-2000 Display (TFT Display)

Assembly.................................................... 5-2
5.1.3 MEC-2000 Support Assembly (Lead-Acid)(9201-30-

35945)............................ 5-3
5.1.4 Front Cover

Assembly...........................................................................
............. 5-4
5.1.5 4.1.5 Back Cover
Assembly ..........................................................................
..... 5-5
5.2
Troubleshooting ...................................................................
........................................... 5-7
5.2.1 Black Screen, Startup

Failure............................................................................
. 5-7
5.2.2 White Screen & Other Abnormal

Screen ........................................................... 5-8
5.2.3 Encoder
Faults.............................................................................
....................... 5-8
5.2.4 No Audio
Alarm .............................................................................
.................... 5-8
5.2.5 Printing
Failure............................................................................
....................... 5-8
5.2.6 Abnormal Paper

Drive..............................................................................
.......... 5-8
6 Test and Material

List...............................................................................
....................... 6-1
6.1 Test
Procedure..........................................................................
....................................... 6-1
6.1.1 Connection and

Checking ..........................................................................
........ 6-1
6.1.2 2 Functions of
Buttons ...........................................................................
............ 6-1
6.1.3
ECG/RESP ..........................................................................
............................... 6-1
6.1.4
Temperature........................................................................
................................ 6-2
6.1.5
NIBP...............................................................................
.................................... 6-2
6.1.6
SpO2...............................................................................
.................................... 6-2
6.1.7
IBP ...............................................................................
...................................... 6-3
2
6.1.8
CO ................................................................................
...................................... 6-3
6.1.9
CO2 ...............................................................................
..................................... 6-4
6.1.10 Water
trap ..............................................................................
........................... 6-4
6.1.11
Recorder ..........................................................................
................................. 6-5
6.1.12 Power
Supply ............................................................................
....................... 6-5
6.1.13
Clock .............................................................................
................................... 6-5
6.1.14 System
Test ..............................................................................
........................ 6-5
6.2 NIBP
Calibration........................................................................
..................................... 6-6
6.3 IBP
CALIBRATE..........................................................................
.................................. 6-6
6.3.1 IBP Transducer

Zero ..............................................................................
............ 6-6
6.3.2 IBP
Calibration........................................................................
........................... 6-8
6.4 CO2
CHECK..............................................................................
................................... 6-10
6.5 MEC-2000 Material
List ..............................................................................
..................6-11
7 Maintenance and
Cleaning...........................................................................
................... 7-1
7.1 6.1
Maintenance .......................................................................
....................................... 7-1
7.1.1 Checking Before

Using .............................................................................
......... 7-1
7.1.2 Regular
Checking...........................................................................
.................... 7-1
7.2
Cleaning ..........................................................................
................................................ 7-1
7.3 Cleaning
Reagent ...........................................................................
.................................7-1
7.4
Sterilization .....................................................................
................................................ 7-2
7.5
Disinfection.......................................................................
............................................. 7-2
3
FOR YOUR NOTES
1 Safety
1.1 Safety Information

DANGER
�
Indicates an imminent hazard that, if not avoided, will result in death or serious
injury.
WARNING
�
Indicates a potential hazard or unsafe practice that, if not avoided, could result
in
death or serious injury.
CAUTION
�
Indicates a potential hazard or unsafe practice that, if not avoided, could result
in
minor personal injury or product/property damage.
NOTE
�
Provides application tips or other useful information to ensure that you get the
most from your product.
1-1
1.1.1 DANGER
DANGER
�
Do not use flammable gases such as anesthetics, or flammable liquids such as
ethanol, near this product, because there is danger of explosion.
1.1.2 Warnings
WARNING
�
Do not connect this system to outlets with the same circuit breakers and fuses
that control current to devices such as life-support systems. If this system
malfunctions and generates an over current, or when there is an instantaneous
current at power ON, the circuit breakers and fuses of the building�s supply
circuit may be tripped.
1.1.3 Cautions
CAUTION
�
Malfunctions due to radio waves.
�
Use of radio-wave-emitting devices in the proximity of this kind of medical
electronic system may interfere with its operation. Do not bring or use devices
which generate radio waves, such as cellular telephones, transceivers, and radio
controlled toys, in the room where the system is installed.
�
If a user brings a device which generates radio waves near the system, they must
be instructed to immediately turn OFF the device. This is necessary to ensure
the proper operation of the system.
�
Do not allow fluids such as water to contact the system or peripheral devices.
Electric shock may result.
1-2
1.2 Equipment Symbols
NOTE
�
Some symbols may not appear on your equipment.
Attention: Consult accompanying documents (this manual).
Power ON/OFF
Power ON/OFF
Alternating current (AC)
Battery indicator
Type CF applied part. The unit displaying this symbol contains an
F-type isolated (floating) patient part providing a high degree of
protection against shock, and is suitable for use during defibrillation.
TYPE BF applied part. Defibrillator-proof protection against
electrical shock.
Equipotentiality
Auxiliary output
Network connector
VGA connector
AG module connector
Gas inlet
Gas outlet
1-3
ESD sensitivity
Manufacture date
Serial number
European community representative
This mark means that this device is fully in conformance with the
Council Directive Concerning Medical Devices 93/42/EEC. The
number adjacent to the CE marking (0123) is the number of the
EU-notified body that certified meeting the requirements of Annex
II of the Directive.
The following definition of the WEEE label applies to EU member
states only.
This symbol indicates that this product should not be treated as
household waste. By ensuring that this product is disposed of
correctly, you will help prevent bringing potential negative
consequences to the environment and human health. For more
detailed information with regard to returning and recycling this
product, please consult the distributor from whom you purchased it.
* For system products, this label may be attached to the main unit
only.
1-4
2 About the Product
2.1 Introduction
The MEC-2000 Patient Monitor, a portable and accessible patient monitor, is
supplied by
rechargeable batteries or external AC power, which applies to adults, pediatric and
neonates.
You can select different configurations as required. Besides, the MEC-2000 can be
connected
with the central monitoring system whereby a monitoring network will be formed.
Parameters that the MEC-2000 can monitor include: ECG, RESP, SpO2, NIBP, 2-channel
TEMP, 2-channel IBP, CO and CO2. It, integrating the functions of parameter
measurement,
waveform monitoring, freezing and recording, is a compact and lightweight patient
monitor.
Its color TFT LCD is able to show patient parameters and 8 waveforms clearly. The
compact
control panel and knob control, and the easy-to-use menu system enable you to
freeze, record,
or perform other operations conveniently.
The MEC-2000 Patient Monitor measures patient�s ECG, NIBP, SpO2, TEMP, RESP, IBP,
CO and CO2 physiological signals through the ECG electrode, SpO2 sensor, cuff,
temperature sensor and pressure transducer. During the measurement, the patient
monitor
does not get energy or any substance from the human body, and does not release any
substance to the human body. However, it releases sine wave signals to the patient
when
measuring the respiration rate. The patient monitor converts the measured
physiological
signals to the digital signals, waveforms and values, and then displays them on the
screen.
You can control the patient monitor through the control panel. For example, you can
set
different alarm limits for different patients. Thus, when the patient monitor
detects any
physiological parameter exceeding the preset alarm limit, it will enable the audio
and visual
alarm.
2.2 Application
2.2.1 General
In the treatment processes, it is necessary to monitor important physiological
information of
patients. Therefore, the patient monitor has been playing an outstanding role among
medical
devices. The development of technology does not only help medical staff get the
important
physiological information, but also simplifies the procedures and makes it more
effective. For
patients in hospital, the basic and important physiological information is
required, including
ECG, SpO2, RESP, IBP, CO, CO2, TEMP, etc. In recent years, the development of
science
and technology helping measure and get important physiological information of
patients has
made the patient monitor more comprehensive in performance and better in quality.
Today,
multi-parameter patient monitors are widely used.
2-1
2.2.2 Usage
Parameters that the MEC-2000 can monitor include: ECG, RESP, SpO2, NIBP, TEMP, IBP,
CO and CO2. MEC-2000 converts these physiological signals to digital signals,

processes
them and displays them on the screen. You can set the alarm limit as required. When
the
monitored parameter exceeds the preset alarm limit, the patient monitor will start
the alarm
function. In addition, you can control the patient monitor through the control
panel. Usually,
patient monitors are seen in some clinical areas in hospital, such as ICU, CCU,
intensive care
units for heart disease patients, operating rooms, emergency departments and
observation
wards. They can also be used in clinics. The MEC-2000 patient monitor should be run
under
the control of clinical staff.
MEC-2000 patient monitor has the following functions:

ECG Heart Rate (HR)
2-channel ECG waveform
Arrhythmia analysis and S-T analysis (optional)
RESP Respiration Rate (RR)
Respiration waveform
SpO2 Pulse Oxygen Saturation(SpO2), Pulse Rate (PR)
SpO2 Plethysmogram
NIBP Systolic pressure (NS), diastolic pressure (ND), mean pressure
(NM)
TEMP T1, T2, TD
IBP CH1: SYS, DIA
CH2: SYS, DIA
IBP waveform
CO Temperature of blood (TB)
Cardiac Output (CO)
CO2 End-tidal carbon dioxide (EtCO2)
Inspired minimum CO2 (InsCO2)
Airway Respiration Rate (AwRR)
The MEC-2000 provides the functions of audio/visual alarm, trend graphic storage
and
output, NIBP measurement, alarm event identification, large font screen,
defibrillator
synchronization, oxyCRG recall, drug calculation, etc.
2-2
3 Principles
3.1 General
The intended use of the MEC-2000 patient monitor is to monitor a fixed set of
parameters
including ECG, RESP, SpO2, NIBP, TEMP, IBP, CO and CO2 (IBP, CO and CO2 are
optional). It consists of the following functional parts:
�
Parameter measurement;
�
Main control part;
�
Man-machine interface;
�
Power supply;
�
Other auxiliary functions;
These functional units are respectively detailed below.
Figure 2-1 Structure of the MEC-2000
3-1
3.1.1 Parameter Measurement
The parameter measurement and monitoring are the core functions of the patient
monitor. The
parameter measurement part of the MEC-2000 patient monitor consists of the
measurement
probe, parameter input socket assembly, NIBP assembly and the main control board.
This part converts the physiological signals to electric signals, processes the
those signals and
conducts the calculation by the preset program or command delivered from the main
control
board, and then sends the values, waveforms and alarm information (which will be
displayed
by using the man-machine interface) to the main control board.
3.1.2 Main Control Part

In the MEC-2000 patient monitor, the main control part refers to the main control
part of the
main control board. It drives the man-machine interface, manages the parameter
measurement and provides users with other special functions, such as storage,
recall of
waveforms and data. (See Figure 2-1)
3.1.3 Man-Machine Interface

The man-machine interface of the MEC-2000 patient monitor includes the TFT display,
recorder, speaker, indicator, buttons and control knob.

The TFT display is the main output interface. It, with the high resolution,
provides users with
abundant real-time and history data and waveforms as well as various information
and alarm
information.
The recorder is a subsidiary of the display, which is used for the user to print
data.
The speaker provides the auditory alarm function.
The indicator provides additional information about the power supply, batteries,
alarms and
so on.
The buttons and control knob are the input interface, which are used for the user
to input the
information and commands to the patient monitor.
3.1.4 Power Supply

The power supply part is an important part of the patient monitor. It includes the
main power
PCB, backlight board, batteries and fan.
The main power PCB converts the external AC current respectively to the 5V DC and
12V
DC current, which are supplied for the whole system. For the TFT display, there is
a special
requirement on the power supply, so a backlight board is used. The batteries supply
power for
the system for a short time when there is no external AC current. The fan is used
for the heat
sink of the system.
3.1.5 Other Auxiliary Functions

The MEC-2000 patient monitor also provides the network upgrade function for the
service
engineers to upgrade the system software without disassembling the enclosure.
3-2
3.2 Hardware Description
The structure of the MEC-2000 patient monitor is shown in the following figure.
Figure 2-2 Functional structure of the MEC-2000

The MEC-2000 PCB connection is shown in the following figure.
Figure 2-3 PCB connection

Basic functions and working principles of modules are described in the following
sections.
3-3
3.2.1 Main Board
3.2.1.1 General
The main board is the heart of the patient monitor. It implements a series of
tasks, including
the system control, system scheduling, system management, data processing, file
management, display processing, printing management, data storage, system diagnosis
and
alarm.
3.2.1.2 Principle diagram

Figure 2-4 Working principle of the main board
3.2.1.3 Principle
The main board is connected with external ports, including the power input port,
multi-way
serial port, TFT display interface, analog VGA interface, network port and analog
output port.
Besides, on the main board is also a BDM interface reserved for the software
debugging and
software downloading.
CPU System
CPU is the core part of the main board. It, connected with other peripheral modules
through
the bus and I/O cable, implements the data communication, data processing, logical
control
and other functions.
RTC
RTC provides the calendar information (such as second, minute, hour, day, month and
year).
CPU can read and modify the calendar information from RTC.
3-4
Ethernet Controller
Ethernet Controller supports the IEEE802.3/IEEE802.3u LAN standard, and supports

two
data transmission rate: 10Mbps and 100Mbps. CPU exchanges data with the Ethernet
through
the Ethernet Controller.
Analog Output
The D/A converter converts the digital ECG/IBP signals sent from CPU to the analog
signals,
which are provided for the external after low-pass filtered by the filter and
amplified by the
amplifier.
FPGA and VRAM
VRAM stores the displayed data. CPU stores the displayed data to VRAM through FPGA.
FPGA gets data from VRAM, processes them, and then sends them to the relevant
graphic
display device.
In addition, FPGA also extends multiple serial ports, which communicate with
peripheral
modules. FPGA transfers the received data to CPU through the bus; CPU delivers data
to
FPGA through the bus, and then the FPGA transfers those data to the peripheral
modules.
Watchdog
When powered on, watchdog provides reset signals for CPU, FPGA and Ethernet
Controller.
The patient monitor provides the watchdog timer output and voltage detection
functions.
3-5
3.2.2 ECG/RESP/TEMP Module
3.2.2.1 General
This module provides the function of measuring three parameters: electrocardiograph
(ECG),
respiration (RESP) and temperature (TEMP).

Figure 2-5 Working principle of the ECG/RESP/TEMP module
3.2.2.3 Principle
This module collects the ECG, RESP and TEMP signals through the transducer,
processes the
signals, and sends the data to the main board through the serial port.
ECG Signal Input Circuit
The input protection and filtering circuits receive the ECG signal from the
transducer, and
filter the high-frequency interference signal to protect the circuit against the
damage by
defibrillator high-voltage and ESD.
The right-leg drive circuit gets the 50/60Hz power common-mode signal from the lead
cable,
and sends the negative feedback signal to the human body to reject the common-mode
interference signal on the lead cable, which helps the detection of the ECG signal.
The lead-off detecting circuit checks whether the ECG lead is off, and sends the
information
to CPU.
ECG Signal Process Circuit
The difference amplifying circuit conducts the primary amplification of the ECG
signal and
rejects the common-mode interference signal.
The low-pas filtering circuit filters the high-frequency interference signal beyond
the
frequency band of the ECG signal.
3-6
The PACE signal refers to the ECG pace signal. It has significant interference to
the ECG
signal detection. The PACE rejection circuit can rejects the PACE signal, which
helps the
ECG signal detection.
The main amplifying/filtering circuit conducts the secondary amplification of the
ECG signal,
filters the signal, and then sends the ECG signal to the A/D conversion part.
Pace Detect
This part detects the PACE signal from the ECG signal and sends it to CPU.
Temperature Detect Circuit
This circuit receives the signal from the temperature transducer, amplifies and
filters it, and
then sends it to the A/D conversion part.
Carrier Generate Circuit
The RESP measurement is based on the impedance method. While a man is breathing,
the
action of the breast leads to changes of the thoracic impedance, which modulates
the
amplitude of the high-frequency carrier signal. Finally, the modulated signal is
sent to the
measurement circuit. The purpose of this module is generating the high-frequency
carrier.
RESP Signal Input Circuit
This circuit couples the RESP signal to the detecting circuit.
RESP Signal Process Circuit
The pre-amplifying circuit conducts the primary amplification of the RESP signal
and filters
it.
The detecting circuit detects the RESP wave that has been modulated on the
actuating signal.
The level shifting circuit removes the DC component from the RESP signal.
The main amplifying/filtering circuit conducts the secondary amplification of the
RESP
signal, filters the signal, and then sends it to the A/D conversion part.
A/D
The A/D conversion part converts the analog signal to the digital signal, and sends
the signal
to CPU for further processing.
CPU System
�
Implementing the logical control of all parameter parts and A/D conversion parts;
�
Implementing the data processing for all parameters;
�
Implementing the communication with the main board.
3-7
Power & Signal isolate Circuit
�
Isolating the external circuits to ensure the safety of human body;
�
Supplying power for all circuits;
�
Implementing the isolation communication between the CPU System and the main
board.
3.2.3 CO/IBP Module
3.2.3.1 General
This module provides the function of measuring two parameters: Cardiac Output (CO)
and
Invasive Blood Pressure (IBP).

Figure 2-6 Working principle of the CO/IBP module
3.2.3.3 Principle
This module collects the CO/IBP signal through the transducers, processes it and
sends it to
the main board throgh the serial port.
CO Signal Process Network
The CO parameter is measured with the thermal dilution method. The transducer sends
two
signals (TI: Temperature of Injectate; TB: Temperature of Blood) to the CO Signal
Process
Network. After that, the signals are amplified and low-pass filtered, and then sent
to the CPU
System for processing.
3-8
IBP Signal Process Network
The IBP signal is the differential signal. After the common-mode filtering, the
difference
signal is amplified by the difference amplifying circuit which changes the dual-end
signal to
the single-end signal. After the low-pass filtering, the IBP signal is sent to the
CPU System
for processing.
CPU System
�
Converting the analog signal obtained by the circuit to the digital signal;
�
Implementing the logical control of all parameter parts;
�
Implementing the data processing for the two parameters;
�
�
�
�
board.
3.2.4 SpO2 Module
3.2.4.1 General
This module provides the function of measuring the Pulse Oxygen Saturation (SPO2).

Figure2-7 Working principle of the SpO2 module
3-9
3.2.4.3 Principle
The SpO2 measurement principle
Collecting the light signal of the red light and infrared transmitting through the
finger or toe
which is pulsing;
Processing the collected signal to get the measured result.
The drive circuit of the LED and the gain of the amplifying circuit should be
controlled
according to the different perfusions and transmittances of the tested object.
Led Drive Circuit
This circuit supplies the LED with the drive current, which can be regulated.
SPO2 Signal Process Network
The pre-amplifying circuit converts the photoelectric signal to the voltage signal
and
conducts the primary amplification.
The gain adjusting and amplifying circuit conducts the secondary signal
amplification and
adjusts the gain.
The biasing circuit adjusts the dynamic range of the signal, and sends it to the
A/D
conversion part.
A/D
The A/D conversion part converts the analog signal to the digital signal, and then
sends it to
CPU for further processing.
D/A
The D/A conversion part converts the digital signal received from CPU to the analog
signal,
and provides the control signal for the Led Drive Circuit and SPO2 Signal Process
Network.
CPU System
�
Implementing the logical control of all the circuits;
�
Implementing the data processing for the SpO2 parameter;
�
�
�
�
board.
3-10
3.2.5 NIBP Module
3.2.5.1 General
This module provides the function of measuring the Non-Invasive Blood Pressure
(NIBP)
parameter.

Figure 2-8 Working principle of the NIBP module
3.2.5.3 Principle
The NIBP is measured based on the pulse vibration principle. Inflate the cuff which
is on the
forearm till the cuff pressure blocks the arterial blood, and then deflate the cuff
according to a
specified algorithm. While the cuff pressure is decreasing, the arterial blood has
pulses,
which are sensed by the pressure transducer in the cuff. Consequently, the pressure
transducer,
connected with the windpipe of the cuff, generates a pulsation signal, which is
then processed
by the NIBP module to get the NIBP value.
Valve Drive Circuit
This circuit controls the status (ON/OFF) of valves. It, together with the Motor
Drive Circuit,
implements the inflation and deflation of the cuff.
Motor Drive Circuit
This circuit controls the action of the air pump. It, together with the Valve Drive
Circuit,
implements the inflation and deflation of the cuff. Besides, it provides the status
signal of the
motor for the A/D conversion part.
3-11
NIBP Signal Process Network
The NIBP signal is the differential input signal. The difference amplifying circuit
amplifies
the dual-end difference signal and converts it to the single-end signal; meanwhile,
this circuit
sends a channel of signal to the A/D conversion part, and the other to the DC
isolating and
amplifying circuit.
The DC isolating and amplifying circuit removes DC components from the signal,
amplifies
the signal, and then sends it to the A/D conversion part.
A/D
The A/D conversion part converts the analog signal to the digital signal, and sends
it to the
CPU System for further processing.
Over Pressure Detect
The circuit detects the NIBP pressure signal. Once the pressure value exceeds the
protected
pressure value, it will send a message to the CPU System, which asks the Valve
Drive Circuit
to open the valve to deflate the cuff.
CPU System
�
Implementing the logical control of all the circuits;
�
Implementing the data processing for the NIBP parameter;
�
3.2.6 Recorder Module
3.2.6.1 General
This module is used to drive the heat-sensitive printer.

Figure 2-9 Working principle of the recorder module
3-12
3.2.6.3 Principle
This module receives the to-be-printed data from the main board, converts them to
the dot
matrix data, sends them to the heat-sensitive printer, and drives the printer.
Step Motor Drive Circuit
There is a step motor on the heat-sensitive printer. The step motor drives the
paper. This
circuit is used to drive the step motor.
Printer Status Detect Circuit
This circuit detects the status of the heat-sensitive printer, and sends the status
information to
the CPU system. The status information includes the position of the paper roller,
status of the
heat-sensitive recorder paper and the temperature of the heat-sensitive head.
CPU System
�
Processing the data to be printed;
�
Controlling the heat-sensitive printer and step motor;
�
Collecting data about the status of the heat-sensitive printer, and controlling the
printer;
�
3.2.7 Button Panel
3.2.7.1 General
This module provides a man-machine interactive interface.

Figure 2-10 Working principle of the button panel
3-13
3.2.7.3 Principle
This module detects the input signals of the button panel and control knob,
converts the
detected input signals to codes and then sends to the main board. The main board
sends
commands to the button panel, which, according to the commands, controls the status
of the
LED and the audio process circuit to give auditory/visual alarms.
CPU
�
Detecting the input signal of the button panel and control knob;
�
Controlling the status of LED;
�
Controlling the audio process circuit;
�
Regularly resetting the Watchdog timer;
�
Communicating with the main board.
Audio Process Circuit
This circuit generates audio signals and drives the speaker.
Watchdog
When powered on, the Watchdog provides the reset signal for CPU.
The patient monitor provides the watchdog timer output and voltage detection
functions.
3.2.8 Power PCB

3.2.8.1 General
This module provides DC working current for other boards.

Figure 2-11 Working principle of the power PCB
3-14
3.2.8.3 Principle
This module can convert 220V AC or the battery voltage to 5V DC and 12V DC
voltages,
which are supplied for other boards. When the AC voltage and batteries coexist, the
AC
voltage is supplied for the system and used to charge the batteries.
AC/DC
This part converts the AC voltage to the low DC voltage for the subsequent
circuits; besides,
it supplies the power for charging the batteries.
Battery Control Circuit
When the AC voltage and batteries coexist, this circuit controls the process of
charging the
batteries with the DC voltage converted by the AC/DC part. When the AC voltage is
unavailable, this circuit controls the batteries to supply power for the subsequent
circuits.
5V DC/DC
This part converts the DC voltage to the stable 5V DC voltage and supplies it for
the external
boards.
12V DC/DC
This part converts the DC voltage to the stable 12V DC voltage and supplies it for
the
external boards.
Power Switch Circuit
This circuit controls the status of the 5V DC/DC part and the 12V DC/DC part, thus
to
control the switch of the patient monitor.
Voltage Detect Circuit
This circuit detects the output voltages of the circuits, converts the analog
signal to the digital
signal, and sends the digital signal to the main board for processing.
3-15
3.3 Software Description
3.3.1 General
Figure 2-12 System function
As shown in Figure 2-12, in the red frame is the software system, on the left to
the red frame
are the inputs of the software system, and on the right to the red frame are the
outputs. The
parameter measurement module exchanges data with the software through the serial
port,
while the user interacts with the system through the button panel. Among the output
devices,
the recorder and alarm device receive data through the serial ports, the analog
output
component is an MBUS component, and the LCD and network controller are controlled
directly by CPU.
3-16
3.3.2 System Task
NO Task Function Period
1 System initialization Initializing the system
In case of a
startup
2 Data processing Analyzing and saving the data 1 second
3
Display of timer
information
Implementing the timed refreshing 1 second
5
Switchover of modules
and screens
Switching over between waveforms and
parameters on the screen
In case of a
screen change
event
6
Processing of user
commands and screens
Processing the user inputs by buttons and
displaying them on the screen.
In case of a
button event
7 System monitoring
System monitoring, voltage monitoring and
battery management
1 second
8 Network connection Implementing the network connection 1 second
9 Network data sending Sending the network data 1 second
10 Network data receiving Receiving the network data (viewbed) 1 second
11 ECG analysis
Analyzing ECG signal, calculating ECG values
(HR, ARR and ST), and saving the analysis
results.
1 second
12 Record output Outputting records
In case of a
record event
13 NIBP processing Implementing NIBP-related processing 1 second
14 WATCHDOG task Managing the system watchdog 1 second
3-17
3.3.3 System Function
The system tasks can be classified as follows.
Figure 2-13 System task
3-18
3.4 System Parameter
3.4.1 General
For the MEC-2000 patient monitor, signals are collected by modules, and the results
are
transferred to the main board through the adapter board, thus to process and
display the data
and waveforms. Commands from the main board, as well as the status information of
modules, are transferred through the adapter board. In addition, the adapter board
adapts and
changes the power supply. The structure of the whole system is shown in the
following
figure.
Figure 2-14 System structure

As shown in Figure 2-14, the five modules and measurement cables monitor and
measure
NIBP, SpO2, ECG/RESP/TEMP, IBP/CO and CO2 in real time, and send the results to the
main board for processing and displaying. If necessary, the results are sent to the
recorder for
printing.
The parameter monitoring functions are described respectively in the following

sections.
3-19
3.4.2 ECG/RESP
�
ECG
The MEC-2000 patient monitor has the following ECG functions:
1) Lead type: 3-lead, 5-lead, 12-lead
2) Lead way:
3-lead (1 channel): I, II, III
5-lead (2 channels): I, II, III, aVR, aVL, aVF, V
12-lead (8 channels): I, II, III, aVR, aVL, aVF, V1-V6, CAL
3) Floating input
4) Right-foot drive
5) Lead-off detection
6) 2-channel ECG waveform amplification; processing ECG signals of any two leads
�
The ECG circuit processes the ECG signals. It consists of the following parts:
1) Input circuit: The input circuit protects the ECG input level, and filters the
ECG signals
and external interference. The ECG electrode is connected to the input circuit
through the
cable.
2) Buffer amplifying circuit: This circuit ensures extremely high input impedance
and low
output resistance for ECG.
3) Right-foot drive circuit: The output midpoint of the buffer amplifying circuit
is fed to the
RL end of the 5-lead after the inverse amplification, so as to ensure that the
human body is in
the equipotential state, decrease the interference, and increase the common-mode
rejection
ratio of the circuit.
4) Lead-off detection: The lead-off causes changes in the output level of the
buffer
amplifying circuit. Therefore, the lead-off can be detected with a comparator, and
the state of
lead-off can be converted TTL level for the Micro Controller Unit (MCU) to detect
it.
5) Lead circuit: Under the control of MCU, the lead electrodes should be connected
to the
main amplification circuit.
6) Main amplification circuit: The measurement amplifier is composed of 3 standard
operation amplifiers.
7) Subsequent processing circuit: This circuit couples the ECG signals, remotely
controls the
gains, filters the waves, shifts the level, amplifies the signal to the specified
amplitude, and
sends the signal to the A/D converter.
�
RESP
The MEC-2000 patient monitor measures the RESP based on the impedance principle.
While
a man is breathing, the action of the breast leads to impedance changes between RL
and LL.
Change the high-frequency signal passing the RL and LL to amplitude-modulation
high-frequency signal (AM high-frequency signal), which is converted to the
electric signal
after being detected and amplified and then sent to the A/D converter. The RESP
module
consists of the RESP circuit board and coupling transformer. The circuit has
several functions:
vibration, coupling, wave-detection, primary amplification and high-gain
amplification.
3-20
3.4.3 NIBP
The NIBP is measured based on the pulse vibration principle. Inflate the cuff which
is on the
forearm till the cuff pressure blocks the arterial blood, and then deflate the cuff
according to a
specified algorithm. While the cuff pressure is decreasing, the arterial blood has
pulses,
which are sensed by the pressure transducer in the cuff. Consequently, the pressure
transducer,
connected with the windpipe of the cuff, generates a pulsation signal. Then, the
pulsation
signal is filtered by a high-pass filter (about 1Hz), amplified, converted to the
digital signal
by the A/D converter, and finally processed by the MCU. After that, the systolic
pressure,
diastolic pressure and mean pressure can be obtained. For neonates, pediatric and
adults, it is
necessary to select the cuffs of a proper size to avoid possible measurement
errors. In the
NIBP measurement, there is a protection circuit used to protect patient from over-
high
pressure.
The NIBP measurement modes include:

1) Adult/pediatric/neonate mode: To be selected according to the build, weight and
age of the
patient;
2) Manual/Auto/Continuous mode: The manual measurement is also called single
measurement; in this mode, only one measurement is done after being started. In the
auto
measurement mode, the measurement can be done once within the selected period, with
the
interval being 1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 180, 240 or 480 minutes. In
the continuous
measurement mode, quick continuous measurement will be done within 5 minutes after
being
started; it detects the changes in blood pressure effectively.
3.4.4 SpO2
The SpO2 value is obtained through the pulse waves of the finger tips based on
specific
algorithm and clinical data. The SpO2 probe is the measurement transducer. It has
two inbuilt
LEDs and an inbuilt light receiver. The two LEDs include one red-light diode and
one
infrared diode, which emit light in turns. When the capillaries in the finger tip
are iteratively
congested with blood pumped by the heart, the light emitted by the LEDs, after
absorbed by
the capillaries and tissue, casts on the light receiver, which can sense, in the
form of electric
signal, the light strength changing with the pulsated blood. The DC/AC ratio of the
two
photoelectric signals corresponds to the content of the oxygen in the blood.
Therefore, the
correct pulse oxygen saturation can be obtained with specific algorithm. Moreover,
the pulse
rate can be obtained according to the pulse waveform.
The circuit of the SpO2 module is involved in four parts: SpO2 probe, signal
processing unit,
LED-driven sequencing control part and the MCU.
3-21
3.4.5 TEMP
Temperature measurement principle:
1. The transducer converts the body temperature to the electric signal;

2. The amplifier amplifies the electric signal;
3. The CPU processes the data.
The circuit is a proportional amplifier consisting of operation amplifiers. When
the
temperature reaches the heat-sensitive probe, the heat-sensitive probe generates
the voltage
signal, which is sent to the A/D converter after being amplified. The probe
detecting circuit is
a voltage comparator consisting of operation amplifiers. When the probe is
disconnected, the
voltage input is lower than the comparing voltage, so the voltage comparator
outputs the low
level; when the probe is connected, the voltage input is higher than the comparing
voltage, so
the voltage comparator outputs the high level.
3.4.6 IBP
The IBP module can monitor the arterial pressure, central venous pressure and
pulmonary
arterial pressure.
Measurement principle: Introduce a catheter, of which the external end is connected

to the
pressure transducer, into the blood vessel under test, inject the physiological
saline. Since the
liquid can be transferred by pressure, the pressure inside the blood pressure is
transferred by
liquid to the pressure transducer, and the dynamic waveform of the pressure inside
the blood
pressure is obtained in real time. Thus, the arterial pressure, central venous
pressure and
pulmonary arterial pressure are obtained based on specific algorithm.
3.4.7 CO
CO measurement principle: The thermal dilution method is widely used in the
clinical CO
monitoring. Introduce a floating catheter into the pulmonary artery through the
right atrium,
and inject the physiological saline into the right atrium through the catheter
whose front end
is connected to the temperature transducer. When the cold liquid mixes with the
blood, there
will be a change of temperature. Thus, when the blood mixed with the physiological
saline
flows into the pulmonary artery, its temperature will be sensed by the temperature
transducer.
According to the injection time and temperature change, the patient monitor can
analyze the
CO, and calculate the Cardiac Index (CI), Stroke Volume Index (SVI), SVIs of the
left atrium
and right atrium, Pulmonary Vascular Resistance (PVR) and so on.
3-22
3.4.8 CO2
The CO2 module works based on the infrared spectrum absorption principle. According
to
different connection methods, the infrared light transducer is classified as
sidestream infrared
light transducer. The sidestream CO2 module is composed of the circuit board,
inbuilt
sidestream infrared light transducer, deflation pump and control. When used, this
module
requires the external water trap, drying pipe and sampling tube. In the sidestream
mode, the
deflation rate can be set to 100ml/min, 150ml/min or 200ml/min according to the
patient
situation. When the CO2 measurement is not being conducted, the sidestream
deflation pump
and the infrared source are expected to be shut down, thus to extend the service
life and
reduce the power consumption of the module. There is no windpipe which is available
in the
sidestream mode.
3-23
FOR YOUR NOTES
3-24
4 Product Specifications
4.1 Safety Classifications

Type of protection
against electric shock
Class I with internal electric power supply.
Where the integrity of the external protective earth (ground) in the
installation or its conductors is in doubt, the equipment shall be
operated from its internal electric power supply (batteries)
Degree of protection
against electric shock
Sidestream CO2:
ECG/RESP/TEMP/SpO2/NIBP/IBP/CO:
BF (defibrillation proof)
CF (defibrillation proof)
against hazards of
ignition of flammable
anesthetic mixtures
Not protected (ordinary)
against harmful ingress
of water
Not protected (ordinary)
Mode of operation Continuous
Equipment type Portable
4.2 Environmental Specifications

Operating temperature
0 to 40.
5 to 35.
(With CO2 module)
Operating humidity 15 to 95%, noncondensing
Operating altitude
-500 to 4600 m (-1640 to 15092 feet)
-305 to 3014 m (-1000 to 9889 feet) (with CO2 module)
Storage temperature -20 to 60.
Storage humidity 10 to 95%, noncondensing
Storage and transportation
altitude
-500 to 13100 m (-1640 to 42979 feet)
-305 to 6096 m (-1000 to 20000 feet) (with CO2 module)
4-1
4.3 Power Source Specifications
AC mains
Input voltage 100 to 240 V
Frequency 50/60 Hz
Power 140 VA
Fuse T 3 A, 250 V
Internal battery
Number of batteries 2
Type Sealed lead-acid battery
Time to shutdown >5 min (after the first low-power alarm)
Sealed lead-acid battery
Nominal voltage 12 VDC
Capacity 2.3 Ah
Operating time
48 minutes or 120 minutes typical when powered by one or two
new fully-charged batteries respectively (25., ECG, SpO2,
NIBP measurement per 15 minutes).
Charge time
A maximum of 6 h for each battery, and a maximum of 12h for
both (in the running status or standby mode)
4.4 Hardware Specifications

Physical
Size 318 � 270 � 145mm (width�height�depth)
Weight
Different due to different configurations
Maximum weight: = 6.5kg
Display
Type Color TFT LCD
Size 12.1 inches (diagonal)
Resolution 800�600 pixels
Recorder
Type Thermal dot array
Horizontal resolution 160 dots/cm (at 25 mm/s recording rate)
Vertical resolution 80 dots/cm
Width of the recorder paper 50 mm
Length of the recorder paper 20 m
Recording rate 25 mm/s, 50 mm/s
Recorded waveforms 2
4-2
LED indicator
Alarm indicator 1 (yellow and red)
Running status indicator 1 (green)
AC power indicator 1 (green)
Audio indicator
Speaker
Giving audio alarms (45 to 85 dB), keypad tones, and
heartbeat/pulse tone.
Supporting PITCH TONE and multi-level volume.
Audio alarms comply with EN475 and IEC60601-1-8.
Connectors
Power supply 1 AC power connector
Network 1 standard RJ45 network connector, 100 BASE-TX
VGA 1 standard color VGA monitor connector, 15-PIN D-sub
Auxiliary output 1 BNC connector
Equipotentiality 1 equipotential grounding connector
4.5 Data Storage

Trend data
Long trend: 96 hours, resolution 1min, 5 min or 10 min.
Short trend: 1 hour, resolution 1 s or 5 s.
Alarm events
70 alarm events and associated waveforms (with user
selectable waveform length 8s, 16 or 32).
ARR events 80 ARR events and associated waveforms with 8s wavelength.
NIBP measurements
800 NIBP groups, including systolic pressures, mean pressures,
diastolic pressures and measurement time.
4-3
4.6 Signal Output Specifications
Standards
Meets the requirements of EC60601-1 for short-circuit
protection and leakage current
Output impedance 50.
ECG analog output
Bandwidth (-3dB; reference
frequency: 10Hz)
Diagnostic mode:
Monitor mode:
Surgery mode:
0.05 to 100 Hz (812A module)
0.05 to 150 Hz (M08A module)
0.5 to 40 Hz
1 to 20 Hz
Maximum propagation delay 25 ms (In DIAGNOSTIC mode, NOTCH is OFF)
Sensitivity 1 V/mV� 5%
PACE rejection/enhancement No pace rejection or enhancement
IBP analog output
Bandwidth 0 to 12.5 Hz (-3 dB, reference frequency: 1 Hz)
Maximum propagation Delay 55 ms (the filter function is disabled)
Sensitivity 1 V/100 mmHg �5%
Nurse call output
Driver Relay
Electrical specifications =60W, =2A, =36VDC, =25VAC
Conducting resistance < 1.
Isolation voltage > 1500 VAC
Signal type Normally open or normally closed, selectable
Defibrillator synchronization pulse
Maximum time delay 35 ms (R-wave peak to leading edge of the pulse)
Amplitude 3.5 V (min) at 3 mA sourcing; 0.8 V (max) at 1 mA sinking
Pulse width 100 ms �10%
Rising and falling time < 3 ms
VGA
Connector type 15-PIN D-sub socket
Signal RGB: 0.7 Vp-p/75O;
Horizontal/vertical synchronization: TTL level
4-4
4.7 ECG Specifications
Lead naming style AHA, EURO
Lead fault
The lead resistance is no greater than 51 kO
and it is in parallel
with a 0.047 �F capacitor, it will not cause a lead fault condition.
For 3/5-lead, differential offsets = �300 mV, it will not cause a
lead fault condition.
Sensitivity selection
1.25 mm/mV (�0.125), 2.5 mm/mV (�0.25), 5 mm/mV (�0.5),
10 mm/mV (�1), 20 mm/mV (�2) and AUTO
Sweep speed 12.5 mm/s, 25 mm/s, 50 mm/s
Bandwidth (-3 dB)
Diagnostic mode:
Monitor mode:
Surgery mode:
0.05 to 100 Hz (812A module)
0.05 to 150 Hz (M08A module)
0.5 to 40 Hz
1 to 20 Hz
Common mode rejection
Diagnostic mode:
Monitor mode:
Surgery mode:
=90 dB
=105 dB
=105 dB
(The notch filter is turned off.)
50/60Hz Notch Filtering The monitor provides software filtering against the 50/60HZ
industrial frequency.
In monitor and surgery modes, the 50/60HZ filter will be turned
on automatically.
In diagnostic mode, the 50/60HZ filter will be turned off.
Input offset current =0.1�A (except currents to drive leads)
Differential input
impedance
= 5M.
Input signal range �8mV (peak-to-peak value)
Accuracy of input signal
reproduction
Methods A and D were used to establish overall system error and
frequency response according to EC11.
Auxiliary current (Leads
off detection)
Active electrode: < 0.1 �A
Reference electrode: < 1 �A
Patient leakage current < 10uA
Recovery time after
defibrillation
< 5s
Calibration signal 1 mV (peak-to-peak value), precision: �5%
ESU protection Incision mode: 300W
Congelation mode: 100W
Restore time: =10s
The monitor complies with the requirements of ANSI/AAMI
EC13: 2002 Section 4.2.9.14.
4-5
ESU noise control The monitor uses the ECG leads meeting the requirements of
AAMI; based on the ECG baseline, the peak noise = 2mV
The monitor complies with the test method in EC13: 2002
Section 5.2.9.14.
HR
Measurement range
Neonate:
Pediatric:
Adult:
15 to 350 bpm
15 to 350 bpm
15 to 300 bpm
Resolution 1 bpm
Precision �1 bpm or �1%, whichever is greater.
Trigger threshold level 200 �V (lead II)
Trigger indication There will be an audible beep on every beat captured.
Heart Rate Averaging The average Heart Rate is computed in line with the ANSI/AAMI
EC13-2002 Section 4.1.2.1 d) as follows:
When the last 3 R-to-R intervals > 1200 ms, compute the average
of the last 4 R-to-R intervals; otherwise, compute the average of
the last 12 R-to-R intervals minus the longest and shortest
intervals.
The displayed Heart Rate is updated once per second.
Heart Rate Meter
Accuracy and Response to
Irregular Rhythm
When tested in accordance with the ANSI/AAMI EC13-2002
Section 4.1.2.1 e), the indicated heart rate after a 20 second
stabilization period is:
Figure 3a (Ventricular Bigeminy) -80�1 bpm
Figure 3b (Slow Alternating Ventricular Bigeminy) -60�1 bpm
Figure 3c (Rapid Alternating Ventricular Bigeminy) -120�1bpm
Figure 3d (Bi-directional Systoles) -90�2 bpm
Response time to heart rate
changes
Meets the requirement of ANSI/AAMI EC13-2002: Section
4.1.2.1 f).
Less than 11 sec for a step increase from 80 to 120 BPM
Less than 11 sec for a step decrease from 80 to 40 BPM
Response time of
tachycardia alarm
When tested in accordance with ANSI/AAMI EC13-2002 Section
4.1.2.1 g, the response time is as follows:
Figure 4ah � range: 15.7 to 19.2s, average: 17.4s
4a � range: 5.7 to 8.5s, average: 7.5s
4ad � range: 3.6 to 5.1s, average: 4.2s
Figure 4bh � range: 11.5 to 14.7s, average: 12.9s
4b � range: 4 to 14s, average: 7.2s
4bd � range: 6.6 to 14.5s, average: 10.5s
Tall T-Wave Rejection When tested in accordance with the ANSI/AAMI EC13-2002
Section 4.1.2.1 c), the heart rate meter will reject all T-waves
with amplitudes less than 1.2 mV, 100 ms QRS, a T wave
duration of 180ms and a Q-T interval of 350 ms.
4-6
Pace pulse
Pulse indicator
Pace pulses meeting the following conditions are marked by the
PACE indicator.
Amplitude:
Width:
Rise time:
�4 to �700 mV (3/5-lead)
0.1 to 2 ms
10 to 100 �s
Pulse rejection
When tested in accordance with the ANSI/AAMI EC13-2002:
Sections 4.1.4.1 and 4.1.4.3, the heart rate meter rejects all pulses
meeting the following conditions.
Amplitude:
Width:
Rise time:
Min. input slew rate:
�2 to �700 mV
0.1 to 2 ms
10 to 100 �s
20 V/s RTI
ST segment measurement
Measurement range -2.0 to +2.0 mV
Precision
-0.8 to +0.8 mV: �0.02 mV or �10%, whichever is greater
Beyond this range: Undefined
Update period 10 s
4.8 RESP Specifications

Measurement technique Thoracic impedance
Lead Optional: lead I and lead II; default lead II
Respiration excitation
waveform
< 300 �A, sinusoid, 62.8 kHz (�10%)
Respiration impedance test
range
0.3 to 3 .
Baseline impedance range 200 to 2500 O (using an ECG cable with 1kO resistance)
Differential input
impedance
> 2.5 M.
Linear Signal Range 3 O p-p minimum
Bandwidth 0.2 to 2 Hz (-3 dB)
Sweep speed 6.25 mm/s, 12.5 mm/s, 25 mm/s
RR
Measurement range
Adult:
Pediatric/neonate:
0 to 120 BrPM
0 to 150 BrPM
Resolution 1 BrPM
Precision
7 to 150 BrPM:
0 to 6 BrPM:
�2 BrPM or �2%, whichever is greater.
Undefined.
Apnea alarm delay 10 to 40 s
4-7
4.9 SpO2 Specifications
SpO2
Measurement range 0 to 100%
Resolution 1%
Precision
70 to 100%:
70 to 100%:
0% to 69%:
�2 % (adult/pediatric, non-motion conditions)
�3% (neonate, non-motion conditions)*
Undefined.
Refreshing rate 1 s
Averaging time
7 s (When the sensitivity is set to High)
9 s (When the sensitivity is set to Medium)
11 s (When the sensitivity is set to Low)
PR
Measurement range 20 to 254 bpm
Resolution 1 bpm
Precision �3 bpm (non-motion conditions)
Refreshing rate 1 s
* A study was performed to validate the accuracy of this monitor with 520N SpO2
sensor.
Totally 122 neonates (65 male & 57 female) aged from 1 day to 30 days with a
gestation
age of 22 weeks to full term were involved in this study. The statistical analysis
of the 200
pairs of data over the range of 72% to 100% SaO2 of this study shows that the
accuracy
(Arms) is 2.47 digits, which is within the stated accuracy specification. Another
study
performed on adult subjects also shows the effectiveness.
This monitor with 520N SpO2 sensor was validated on adult subjects (1.62% Arms) and
that actual performance in the neonatal population was observed.

4-8
4.10 NIBP Specifications
Measurement technique Auto oscillation
Displayed parameters Systolic pressure, diastolic pressure, mean pressure and PR
Mode of operation Manual, auto and continuous
Measurement interval in
auto mode
1/2/3/4/5/10/15/30/60/90/120/180/240/480 minutes
Measurement time in
continuous mode
5 minutes
Measurement range in
normal mode
mmHg Adult Pediatric Neonate
Systolic pressure 40 to 270 40 to 200 40 to 135
Diastolic pressure 10 to 210 10 to 150 10 to 100
Mean pressure 20 to 230 20 to 165 20 to 110
Measurement precision
Maximum average error: �5mmHg
Maximum standard deviation: 8mmHg
Resolution 1mmHg
Static pressure
measurement range
0 to 300mmHg
Static accuracy � 3 mmHg
Over-pressure protection
by software
Adult:
Pediatric:
Neonate:
297�3 mmHg
240�3 mmHg
147�3 mmHg
Over-pressure protection
by hardware
Adult:
Pediatric:
Neonate:
330 mmHg
330 mmHg
165 mmHg
Default start pressure
Adult:
Pediatric:
Neonate:
178�5 mmHg
133�10 mmHg
67�5 mmHg
PR from NIBP
Precision �3 bpm or �3%, whichever is greater
Resolution 1 bpm
4-9
4.11 TEMP Specifications
Number of channels 2
Displayed parameters T1, T2 and TD
Measurement range 0 to 50�C (32 to 122�F)
Resolution 0.1�C
Precision
�0.1�C (excluding the sensor)
�0.2�C (including the YSI 400 series sensor)
Update period 1s
Minimum time for
accurate measurement
Body surface: < 100s
Body cavity: < 80s
(YSI 400 series sensor)
4.12 IBP Specifications

Number of channels 2
Pressure readings Systolic, diastolic, mean pressures and PR
Pressure labels ART, PA, CVP, RAP, LAP, ICP, P1 and P2
Linear input range will be -50 to.300 mmHg, after zeroing.
Measurement range
ART 0 to 300 mmHg
PA -6 to 120 mmHg
CVP/RAP/LAP/ICP -10 to 40 mmHg
P1/P2 -50 to 300 mmHg
Resolution 1 mmHg
Precision �2% or �1mmHg, whichever is greater
Excitation
will be 5 Volts DC, � 2%
Minimum load resistance will be 300O per transducer.
Update period 1s
Zero offset range � 200 mmHg
Zero accuracy � 1 mmHg
Noise <0.5 mmHg RTI, DC to 12.5 Hz, 300O source impedance.
Drift <0.15 mmHg/.; will not exceed � 1 mmHg in 24 hours.
Frequency Response DC-12.5Hz �1 Hz, -3db
PR from IBP
Precision �1 or �1%, whichever is greater.
Resolution 1 bpm
4-10
Pressure transducer
Excitement voltage 5 VDC, �2%
Sensitivity 5 uV/V/mmHg
Impedance range 300 to 3000.
Volume displacement
(ABBOTT)
<0.04 mm3 /100 mmHg
4.13 CO Specifications
Measurement technique Thermal dilution
Calculated parameter CO, hemodynamics
CO 0.1 to 20l/min
Measurement range TB 23 to 43�C
TI 0 to 27�C
Resolution
CO:
TB, TI:
0.1 l /min
0.1�C
Precision
CO:
TB, TI:
�5% or � 0.1 l /min
0.1�C
Alarm range TB: 23 to 43�C
4.14 CO2 Specifications

Measurement technique Infrared absorption technique
Displayed parameter EtCO2, FiCO2, Respiration Rate
CO2 function Meet the requirements of EN864 and ISO9918.
CO2 measurement range 0 to 99mmHg

Precision*
0 to 40 mmHg:
41 to 76 mmHg:
77 to 99 mmHg:
�2 mmHg
�5%
�10%
Resolution 1 mmHg
Drift meet the requirement of accurancy in 6 hours
Sample flow rate 70, 100 ml/min
Precision of deflation rate �15% or 15 ml/min, whichever is great
Start-up time of CO2
module
< 1min, the module enters the warming up status after the startup.
One minute later, it enters the ready-to-measure status.
AwRR measurement range 0 to 120 BrPM
4-11
Precision
0 to 70 BrPM:
> 70 BrPM:
�2 BrPM
�5 BrPM
Response time
When measured with a neonatal watertrap and a 2.5 m-long
neonatal sampling line:
<3.5 s @ 100 ml/min
<4 s @ 70 ml/min
When measured with an adult watertrap and a 2.5 m-long adult
sampling line:
<5.5 s @ 100 ml/min
<7 s @ 70 ml/min
Delay time
When measured with a neonatal watertrap and a 2.5m-long
neonatal sampling line:
<3 s @ 100 ml/min
<3.5 s @ 70 ml/min
When measured with an adult watertrap and a 2.5m-long adult
sampling line:
<5 s @ 100 ml/min
<6.5 s @ 70 ml/min
Apnea alarm delay AwRR: 10 to 40 s
* Conditions for measurements in typical precision:
The measurement is started after the preheating mode of the module;
Ambient pressure: 750 mmHg to 760 mmHg; room temperature: 22. to 28.;
The gas under test is dry, and the balance gas is N2;
The deflation rate is 100 ml/min, the respiration rate is no greater than 50 BrPM,
with a
fluctuation less than �3 BrPM, and the inhale interval/exhale interval is 1:2;
When the working temperature is from 15 to 25 degree, or from 50 to 55 degree, or
when the
breath rate is greater than 50Brpm, the measurement precision should meet the
requirements of
ISO21647: �4mmHg (0 to 40mmHg) or �12% of the reading (41 to 99 mmHg)
4-12
5 Disassembling/Assembling &
Troubleshooting
5.1 MEC-2000 Disassembling/Assembling

5.1.1 Exploded View of MEC-2000
Figure 4-1 Exploded view of MEC-2000
NO Material code Part & Specification Quantity

1 M2K1-30-22652 Front cover assembly 1
2 M2K1-30-22656 Display (TFT Display) assembly 1
3 M04-000305--- Cross-head self-tapping screw 3*12 5
4 M02-000802--- Flat washer GB97.13 4
5 9201-30-36032 Support assembly 1
6 9000-20-05185 - Battery door 1
7 M04-003105--- Cross-head self-tapping screw M3*8 3
8 9201-30-35948 6pin parameter socket 1
9 9100-30-11413 Back cover assembly 1
10 TR6C-30-16668 TR60-C recorder 1
5-1
NO Material code Part & Specification Quantity
11 M04-004012--- Gasketed cross-head screw M3*6 2
14 M04-051140--- Screw assembly M3*8 2
5.1.2 MEC-2000 Display (TFT Display) Assembly

Figure 4-2 MEC-2000 display (TFT display) assembly
NO Standard Name & Specification Quantity

1 M04-004015--- Cross-head screw M3�8 4
2 0010-10-42633 LCD Display screen TFT 12. 1
3 M04-000106--- stud screw M3X7 4
4 9210-20-30180 12.1`back plate-LG 1
5 0000-10-11020 Inverter 2
6 M04-002405--- Cross-head screw M2*6 4
7 M90-000002-01 Insulating washer .2.5 4
5-2
5.1.3 MEC-2000 Support Assembly (Lead-Acid)(9201-30-35945)
Figure 4-3 MEC-2000 support assembly
NO Material Code Part & Specification Quantity

2 9200-20-10689 Recorder regulating panel 1
3 9201-20-36043 Printer mounting plate 1
4 M04-005005--- Cross-head sunk screw M3*6 14
5 9201-30-35952 CF assembly 1
7 9201-20-35965 Support 1
8 9210-30-30150 9210 main control board 1
9 9201-30-35964 Battery compartment assembly (Lead-Acid battery) 1
10 M05-302R3R--- Lead-Acid battery 2
11 9200-20-10516 Insulating plate of ECG board 1
12 812A-30-08557 812A ECG board 1
13 M04-060009--- Stud M3*14 1
14 9200-20-10677 Insulating plate of mounting plate 3 1
5-3
15 9200-20-10676 SPO2/IBP mounting plate 1
16 9006-30-33900 MINDRAY SpO2 module 1
18 M03A-30-26050 IBP/CO module 1
19 9201-20-36012 Power PCB insulating plate 1
20 9201-30-35900 Lead-Acid battery power PCB 1
21 M02B-30-64514 MINDRAY CO2 module 1
22 9210-30-30163 Socket assembly 1
23 630D-30-09121 630D blood pressure pump 1
5.1.4 Front Cover Assembly

Figure 4-4 Front cover assembly

1 9300-20-13772 Front cover 1
2 9200-20-10512 Rubber foot 2
5-4
3 900E-20-04892 connecter 2
4 M08-000249--- LED TRICOLQR 1
5 9300-20-13774 Keybuttons 1
6 9200-20-10473 Keybuttons backstop 1
7 M04-051004--- SCREW PT2.6X6 2
8 9201-30-35912 9201 button panel 1
9 M04-003105--- SCREW PT3X8 4
10 9200-20-10514 Dust washer 2 2
11 9200-20-10513 Dust washer 1 2
12 9200-30-10470 Encoder plate 1
13 9200-20-10548 12.1 TFT panel 1
14 9300-20-13779 Rotary knob 1
15 9300-20-13776 Front face 1
5.1.5 4.1.5 Back Cover Assembly

Figure 4-5 Back cover assembly (CO2) (9201-30-35992)
5-5
NO Material Code Part & Specification Remark
9100-21-11407 Back cover (CO2 module) 1
LBM9-20-09836 Gland 1
9300-20-13821 Handle 1
M04-000802--- Flat washer GB9713 2
M04-000305--- Cross-head self-tapping screw 3*12 2
M02A-20-25905-51 Water-trap Mounting Frame 1
M02A-20-25904 Water-trap plank 1
M04-000501--- Stainless steel nut GB6170MS 1
6200-20-11614 CO2 nozzle 1
9200-20-10511 Foot plate 1 2
9200-21-10633 Speaker 1
9200-20-10620 Speaker press plate 1
9200-20-10622 Hook mounting plate 1
9201-30-35978 Fan assembly 1
M04-003105--- Cross-head self-tapping screw 3*8 8
5-6
5.2 Troubleshooting
5.2.1 Black Screen, Startup Failure
Figure 4-6 Location flow of faults causing black screen
5-7
5.2.2 White Screen & Other Abnormal Screen
In case of faults causing white screen or other abnormal screens,
�
Check whether the LCD connection wires are in good contact;
�
Replace the LCD connection wires, or replace the LCD if necessary;
�
Replace the main control board if the fault still exists.
5.2.3 Encoder Faults
1.
If all other functions (indicator, alarm, buttons) of the button panel are normal,
proceed
to step 2; otherwise, replace the button panel;
2.
Check whether short-circuit or abnormal open-circuit occurs in the encoder pad;
3.
Replace the encoder.
5.2.4 No Audio Alarm
1.
Check whether the audio alarm function is disabled in the software settings;
2.
Replace the speaker;
3.
Replace the button panel.
5.2.5 Printing Failure
1.
Check whether there is any alarm about the recorder. If any, eliminate it;
2.
Check whether the recorder indictor is on;
3.
If not, check the connection wire for inputting signals to the recorder;
4.
Check whether the recorder module is enabled in the maintenance menu;
5.
Check the power cord of the recorder (including the recorder power PCB);
6.
Replace the recorder module.
5.2.6 Abnormal Paper Drive
1.
Check whether there are blocks on the paper roller of the recorder;
2.
Check whether there are blocks in the gear cluster of thermal assembly of the
recorder;
3.
Check whether the voltage input of the recorder is larger than 17.6V.
5-8
6 Test and Material List
6.1 Test Procedure

6.1.1 Connection and Checking
Connect the simulators, power supply and test fixture properly to the MEC-2000
patient
monitor, and power it on. Then, the patient monitor displays the start-up screen on
the TFT
screen and enters the system screen.
6.1.2 2 Functions of Buttons

Press every button on the button panel to check their functions as specified in
MEC-2000
Operation Manual. Rotate the control knob to check its functions.
6.1.3 ECG/RESP
The TFT screen displays the standard ECG waveform, and the error between the heart
rate
and the set value of the simulator is no more than �1, namely 60�1; the RESP
waveform is
smooth, and the respiration rate is 20�1.
1.
Select all leads in order, including Cal, select all the four gains and AUTO,
ensure the
waveforms are displayed properly, and check whether the 50Hz/60Hz interference can
be filtered.
2.
Check, in all the above-mentioned cases, the consistency between the heartbeats,
the
flashes of the red heart-like indicator, and the R-wave.
3.
The gain has no impact on the message �ECG signal over weak� in the HR calculation.
4.
Verify the range and precision: Suppose that the amplitude of the GCG signal of the
simulator is 1mV, the heart rates are respectively 30, 60, 120, 200, 240 and 300.
Check
leads I, II and III. The results should meet 29-31, 59-61, 119-121, 198-202, 238-
242,
and 297-303.
5.
PACE pulse test: Set the simulator to PACE. You should be able to view the pace.
Change PACE amplitude to �8 � 700mv, and pulse width to 0.1ms � 2ms. The PACE
should be legible, and LEAD OFF is displayed properly.
6.
RESP measurement: Set the baseline impedance to 1K, the respiration impedance to
0.5O and 3O, and the respiration rate to 30 and 120. The respiration rate should be
29 �
31, 118 �122.
7.
PVC test: Set the simulator to the PVC mode, and set the occurrence times. The
relevant
PVCS should be obtained.
6-1
8.
Set the simulator as follows: RR: 40, baseline impedance: 2KO, RESP waveform: 3:1.
Open the apnea alarm, set the respiration resistance to 0O, and set various alarm
time.
Alarms should be given.
6.1.4 Temperature
1.
YSI probe
Select YSI probe from the manufacturer menu, select YSI temperature probe as the
test
fixture, set the analog resistance to 1.471K, 1.355K and 1.249K. Then the TEMP
parameter
should be 35�0.1., 37�0.1. and 39�0.1..
2.
CY-F1 probe
Select CY-F1 probe from the manufacturer menu, select CY-F1 temperature probe as
the test
fixture, set the analog resistance to 6.534K, 6.018K and 5.548K. Then the TEMP
parameter
should be 35�0.1., 37�0.1. and 39�0.1..
6.1.5 NIBP
Connect the NIBP simulator, adult cuff and accessories, and then connect the module
CUFF
and clockwise screw it tightly.
1.
After the simulator self-test, press <ENT> to enter the ADULT analog blood pressure
mode. Set the blood pressure to the 255/195/215 mmHg level, SHIFT to +15, and the
HR to 80BPM. Set MEC-2000 to the adult mode. Press <START>. Then the results will
be obtained in about 30s. The measured results should be respectively 270�8mmHg,
210�8mmHg and 230�8mmHg.
2.
Press <ESC> and <.> on the simulator to enter the NEONATE mode. Set the blood
pressure to the 120/80/90 mmHg level, HR to 120bmp, and MEC-2000 to the pediatric
mode. Press <START>. Then the results will be obtained in about 30s. The measured
results should be respectively 120�8mmHg, 80�8mmHg and 90�8mmHg.
3.
Press <ESC> and <.> on the simulator to enter the NEONATE mode. Set the blood
pressure to the 60/30/40 mmHg level, SHIFT to -20, HR to 120bmp, and MEC-2000
to the neonate mode. Change the simulator accessory to the neonatal cuff. Press
<START>. Then the results will be obtained in about 30s. The measured results
should
be respectively 40�8mmHg, 10�8mmHg and 20�8mmHg.
6.1.6 SpO2
Select PLETH as the HR source of MEC-2000, and put the finger into the SpO2 sensor.
The
screen should display the PR and SpO2 values normally. The normal SpO2 value is
above
97%.
6-2
6.1.7 IBP
1. Test fixture
Physiological signal simulator
2. Test procedure
. IBP1 test:
Set the BP sensitivity of the ECG simulator to 5uv/v/mmHg, BP to 0mmHG, and the
IBP channel 1 to ART. Enter the IBP PRESSURE ZERO menu of the MEC-2000, zero
Channel 1, and then return to the main screen. Set the BP of the simulator to
200mmHg.
Enter the IBP PRESSURE CALIBRATE menu of the MEC-2000, conduct calibration,
and then exit the IBP PRESSURE CALIBRATE menu.
Set the BP value of the simulator respectively to 40mmHg, 100mmHg and 200mmHg.
Then the screen of the MEC-2000 should display 40�1mmHg, 100�2mmHg and
200�4mmHg.
Set the simulator output to ART wave. Then the screen of the MEC-2000 should
display
relevant waveform properly.
Unplug the IBP probe. Then the screen should prompt �IBP: Transducer 1 OFF!� and
�IBP: Transducer 2 OFF!�
Plug the OHMEDA cable to the IBP1 channel. Then the prompting message �IBP:
Transducer 1 OFF!� disappears.
. IBP2 test:
Plug the IBP cable to the IBP2 channel, and repeat the procedure in Section
6.1.8 CO
1. Test fixture
Physiological signal simulator
2. Test procedure
Injectate and blood temperature test: Assemble the TB and TI test fixture, output
three
TB temperature values: 36., 37. and 38.. Then TB should be respectively 36.0�0.1
., 37.0�0.1. and 38.0�0.1.. Set the injectate switch to ON, output two TI
temperature values: 0. and 2.. Then the screen should display 0�0.1. and 2.0�0.1
..
CO measurement: Set the CO.CONST and TI to the default values: 0.542 and 0., set
the injectate switch to OFF, and then press START. Then the simulator will output
0.,
2.5L/M and 0., 5L/M within 2s. The CO values should be 2.5�0.25L/M and
5�0.5L/M.
6-3
6.1.9 CO2
1.
Test fixture
CO2 steel bottle (containing 10% CO2)
2.
Test procedure
. Sidestream CO2 measurement: Set the calculation compensation of MEC-2000 to
COMMON.
Plug the water trap to the water trap socket, connect the sampling tube with the
CO2
steel bottle, and open//close the valve of the CO2 steel bottle based on the
interval of 3s.
The CO2 value should be the calibration gas pressure value: 76�5%mmHg. When the
valve is opened permanently, the patient monitor prompts �APNEA ALARM�.
Unplug the water trap. The patient monitor prompts �CO2 water trap OFF�. Plug the
water trap again. The prompting message disappears.
. When the measured value exceeds the high limit of CO2, the patient monitor
prompts �CO2 too high� on the main screen. When the measured value is lower than
the
low limit, the patient monitor prompts �CO2 too low�.
6.1.10 Water trap
1.
Connect the airway and block the inlet of the sampling line with your finger. Check
if
the message CO2 SAMPLE LINE ABNORMAL is displayed and the current pump rate
in the CO2 USER MAINTAIN menu drops below5ml/min. If yes, it indicates the
airway is normal. Otherwise, proceed with step 2.
2.
Remove the sampling line and block the inlet of the water trap with your finger.
Check
if the message CO2 SAMPLE LINE ABNORMAL is displayed and the current pump
rate in the CO2 USER MAINTAIN menu drops below5ml/min. If yes, it indicates
there may be a problem with the connection between the sampling line and water trap
or
a leakage in the sampling line. Otherwise, proceed with step 3.
3.
Remove the water trap and block the two inlets in the receptacle for the water
trap.
Check if the message CO2 SAMPLE LINE ABNORMAL is displayed and the current
pump rate in the CO2 USER MAINTAIN menu drops below5ml/min. If yes, it
indicates there may be a problem with the connection between the water trap and its
receptacle or a leakage in the water trap. Otherwise, there may be a problem with
the
internal airway in the monitor. The internal airway has two parts, one part in the
receptacle and the other part in the module. Block the small tubes between the
water trap
receptacle and module with your fingers and check if the message CO2 SAMPLE LINE
ABNORMAL is displayed and the current pump rate in the CO2 USER MAINTAIN
menu drops below5ml/min. If yes, it indicates there is a problem with the airway in
the receptacle. Replace the receptacle. Otherwise, replace the module.

6-4
6.1.11 Recorder
1.
Print the ECG waveform. The recorder should print it normally and clearly. Set the
recorder to the fault of lack of paper and abnormal clip. There should be relevant
prompting messages on the main screen. When the fault is cleared, the patient
monitor
should become normal.
2.
Print the alarm messages of all parameters. Set the alarm print switch to ON for
all
parameters, and set different alarm limits. Then the recorder should print the
alarm
message in case of an alarm.
6.1.12 Power Supply
When the patient monitor is supplied with the external AC power, the CHARGE
indicator
becomes ON. When it is disconnected from the external AC power, the CHARGE
indicator
becomes OFF. After the patient monitor is started without assembling the batteries,
�x� is
displayed in the battery indication frame on the main screen. After the batteries
are assembled,
the battery electricity is displayed in the battery indication frame on the main
screen. The
patient monitor can work normally with or without batteries. It, however, should
give an
alarm when the batteries are exhausted.
6.1.13 Clock
Verify the correctness of the clock in the system test, and then set the clock to
the current
time.
6.1.14 System Test

Load all parameters, and conduct operations respectively on the loaded parameters.
During
the synchronization, no exceptions (for example, mutual interference) occur. Set
all
parameter setups in menus to the default values which are those at the time of
software
loading, and conduct operations on the menus, for example, managing the patient
information,
recalling data, and so on. All the operations should be done normally, and the
corresponding
functions should be correct and meet the product requirements.
6-5
6.2 NIBP Calibration
Figure 5-1 NIBP Calibration
Calibration method:
Based on the precision of 50mmHg (6.7kPa), increase the pressure step by step. The
maximum error at any pressure point within the NIBP measurement range of the
patient
monitor should be no more than �3mmHg (�0.4kPa). Decrease the pressure step by
step. The
maximum error at any pressure point within the NIBP measurement range of the
patient
monitor should be no more than �3mmHg (�0.4kPa).
6.3 IBP CALIBRATE

6.3.1 IBP Transducer Zero
�
Press the ZERO button on the IBP module to call up IBP PRESSURE ZERO menu as
shown below:
Figure 5-2 IBP PRESSURE ZERO
6-6
Zero Calibration of Transducer
Select CH1, the system will zero IBP1. Select CH2, the system will zero IBP2.
Cautions:
�
Turn off patient stopcock before you start the zero procedure.
�
The transducer must be vented to atmospheric pressure before the zero procedure.
�
The transducer should be placed at the same height level with the heart,
approximately
mid-axially line.
�
Zero procedure should be performed before starting the monitoring and at least once
a
day after each disconnect-and-connect of the cable.
Figure 5-3 IBP Zero
6-7
6.3.2 IBP Calibration
�
Press CAL button on the IBP module to call up the IBP PRESSURE CALIBRATE
menu as shown below:
Figure 5-4 IBP Calibration Menu
Calibrate the transducer:
Turn the knob to select the item CH1 CAL VALUE, press and turn the knob to select
the
pressure value to be calibrated for channel 1. Then turn the knob to select the
item
CALIBRATE to start calibrating channel 1.
Turn the knob to select the item CH2 CAL VALUE, press and turn the knob to select
the
pressure value to be calibrated for channel 2. Then turn the knob to select the
item
CALIBRATE to start calibrating channel 2.
�
The pressure calibration of MEC-2000:
Figure 5-5 IBP Calibration
6-8
You will need the following pieces of equipment:
�
Standard sphygmomanometer
�
3-way stopcock
�
Tubing approximately 25 cm long
The Calibration Procedure:
1.
Close the stopcock that was open to atmospheric pressure for the zero calibration.
2.
Attach the tubing to the sphygmomanometer.
3.
Ensure that connection that would lead to patient is off.
4.
Connect the 3-way connector to the 3-way stopcock that is not connected to the
patient
catheter.
5.
Open the port of the 3-way stopcock to the sphygmomanometer. .
6.
Select the channel to be calibrated in the menu and select the pressure value to
which the
IBP is to be adjusted.
7.
Inflate to make the mercury bar rise to the setup pressure value.
8.
Adjust repeatedly until the value in the menu is equal to the pressure value shown
by the
mercury calibration.
9.
Press the Start button, the device will begin calibrating.
10.
Wait for the calibrated result. You should take corresponding measures based on the
prompt information.
11. After calibration, disassemble the blood pressure tubing and the attached 3-way
valve.
Calibration completion message:�SUCCESSFUL CALIBRATE�
6-9
6.4 CO2 CHECK
Check procedure for sidestream module only
Via the MEC-2000�s system and maintain menus you are prompted for a password for
entering the factory key. After entering the password �332888� you get access to
the pump
rate settings and to check the accuracy of the CO2 measurement. Using the below
test set up
to verify the accuracy of the CO2 module.
Figure 5-6 Sidestream test set up
NOTE
�
The sidestream module can not be calibrated. Only the overall performance and
accuracy is checked. If the Co2 module fails the tests it should be replaced.
Figure 5-7 Factory Maintain Menu Figure 5-8 CO2 check menu
6-10
6.5 MEC-2000 Material List
NO Material Code` Name & Specification Quantity
2 9200-20-10689 Recorder regulating panel 1
3 9200-20-10485 Printer mounting plate 1
4 M04-005005--- Cross-head sunk screw M3*6 14
5 9201-20-35965 Support 1
7 9201-30-35952 CF card assembly 1
8 9210-30-30150 9210 main control board 1
9 9201-30-35964 Battery compartment assembly
(Lead-Acid battery)
1
10 M05-302R3R--- Lead-Acid battery 2
11 9200-20-10516 Insulating plate of ECG board 1
12 812A-30-08557 812A ECG board 1
13 M04-060009--- Stud M3*14 1
15 9200-20-10676 SPO2/IBP mounting plate 1
17 M03A-30-90293 IBP/CO module 1
18 630D-30-09121 630D blood pressure pump 1
19 0010-10-12274 SpO2 module 1
20 9201-20-36012 Power PCB insulating plate 1
21 9201-30-35900 Lead-Acid battery power PCB 1
22 9210-30-30163 Pinboard assembly 1
23 M02B-30-64514 CO2 module (M02B) 1
6-11
FOR YOUR NOTES
6-12
7 Maintenance and Cleaning
7.1 6.1 Maintenance

7.1.1 Checking Before Using
�
Check the patient monitor for mechanical damages;
�
Check all exposed conductors, connectors and accessories;
�
Check all functions that are possibly enabled for the monitored patient, and ensure
the
device is in good working status.
In case of any damage, stop using this patient monitor, and contact biomedical
engineers of
the hospital or Mindray maintenance engineers.
7.1.2 Regular Checking

An all-around check, including the safety check, should be done by qualified
personnel every
6-12 months or after maintenance each time.
All checks in which the patient monitor should be disassembled should be done by
qualified
maintenance personnel. The safety and maintenance checks can be done by Mindray
engineers. The local office of Mindray at your region will be pleased to provide
you with the
information about the maintenance contract.
7.2 Cleaning
Do switch off the patient monitor and disconnect the AC power supply before
cleaning it or
the probes.
The MEC-2000 patient monitor should be dust free. To clean the surface of its
enclosure and
screen, use the cleaning agent that is not corrosive, for example, soap and water.
1.
Do not use strong solvent, such as acetone;
2.
Most cleaning agents must be diluted before being used, so conduct dilution under
the
instruction of manufacturers;
3.
Do not use any erosive material (such as steel wool or polishing agent);
4.
Prevent the ingress of any liquid to the enclosure and any part of the device;
5.
Ensure no residue of cleaning liquid on the surface of the device.
7.3 Cleaning Reagent
1.
Diluted aqua ammonia
2.
Diluted sodium hypochlorite (bleaching powder for washing)
7-1
3.
Diluted formaldehyde 35 � 37%
4.
Hydrogen peroxide 3%
5.
Ethanol
6.
Isopropyl alcohol
7.4 Sterilization
To avoid the long-time damage to the patient monitor, we recommend you
�
To conduct only sterilization which is considered necessary in your maintenance
plan;
�
To clean the patient monitor before the sterilization;
�
To sterilize the patient monitor with specified sterilization agent: Ethylate, and
Acetaldehyde.
For the sterilization agents of the ECG leads and blood pressure cuffs, refer to
relevant
chapters in Operation Manual.
CAUTION
�
Conduct dilution or use the liquid of the possibly-lowest concentration under the
instructions by the manufacturer.
�
Prevent the ingress of liquid to the enclosure.
�
Prevent any part of the system from being dipped.
�
In sterilization, do not spill the liquid to the patient monitor.
�
Ensure no residue of sterilization agent on the surface of the patient monitor.
Clean it if any.
7.5 Disinfection
To avoid the long-time damage to the patient monitor, we recommend you
�
To conduct only disinfection which is considered necessary in your maintenance
plan;
�
To clean the patient monitor before the disinfection;
For the disinfections of ECG leads, SpO2 sensor, blood pressure cuffs and
temperature sensor,
refer to relevant chapters in Operation Manual.
Gas (EtO) or formaldehyde are forbidden for the disinfection of the patient
monitor.
7-2
P/N: 046-000222-00(1.0)

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MEC-2000 Patient Monitor

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called

In the event of inadvertent or deliberate publication, Mindray intends to enforce

All information contained in this publication is believed to be correct. Mindray

Content of this manual is subject to changes without prior notice.

PROPERTY OF SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Responsibility on the manufacturer party

Mindray is responsible for safety, reliability and performance of this equipment

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

Safety, Reliability and Performance

Manufacture: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

3.1.2 Main Control

3.1.5 Other Auxiliary

4.3 Power Source

4.6 Signal Output

5.1.1 Exploded View of MEC-

5.1.2 MEC-2000 Display (TFT Display)

5.1.3 MEC-2000 Support Assembly (Lead-Acid)(9201-30-

5.1.4 Front Cover

5.2.1 Black Screen, Startup

5.2.2 White Screen & Other Abnormal

5.2.6 Abnormal Paper

6 Test and Material

6.1.1 Connection and

6.3.1 IBP Transducer

7.1.1 Checking Before

1.1 Safety Information

CO and CO2. MEC-2000 converts these physiological signals to digital signals,

MEC-2000 patient monitor has the following functions:

3.1.2 Main Control Part

3.1.3 Man-Machine Interface

recorder, speaker, indicator, buttons and control knob.

3.1.4 Power Supply

3.1.5 Other Auxiliary Functions

Figure 2-2 Functional structure of the MEC-2000

Figure 2-3 PCB connection

3.2.1.2 Principle diagram

Ethernet Controller supports the IEEE802.3/IEEE802.3u LAN standard, and supports

FPGA and VRAM

3.2.2.2 Principle diagram

ECG Signal Input Circuit

ECG Signal Process Circuit

Temperature Detect Circuit

Carrier Generate Circuit

RESP Signal Input Circuit

This circuit couples the RESP signal to the detecting circuit.

RESP Signal Process Circuit

3.2.3.2 Principle diagram

CO Signal Process Network

3.2.4.2 Principle diagram

Led Drive Circuit

SPO2 Signal Process Network

3.2.5.2 Principle diagram

Valve Drive Circuit

Motor Drive Circuit

Over Pressure Detect

3.2.6.2 Principle diagram

Step Motor Drive Circuit

Printer Status Detect Circuit