Mindray MEC-1000 Service Manual

MEC-1000 Portable Patient Monitor
Service Manual
Copyright
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. 2003
Version: 1.1 Issued date: May 20, 2005 Series No.: MEC-1000
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 (hereinafter called Mindray) owns all rights to this unpublished work and intends to maintain this work as confidential. Mindray may also seek to maintain this work as an unpublished copyright.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. 2003 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; and,
applied electrical appliance is in compliance with relevant National Standards; and,
MEC-1000 Service Manual (V1.1) I
the monitor is operated under strict observance of this manual.
Note
This equipment is not intended for family usage.
Warning
This monitor is not a device for treatment purpose.
It is important for the hospital or organization that employs this equipment to carry out a reasonable maintenance schedule. Neglect of this may result in machine breakdown or injury of human health.
Upon request, Mindray may provide, with compensation, necessary circuit diagrams, calibration illustration list and other information to help qualified technician to maintain and repair some parts, which Mindray may define as user serviceable.
II MEC-1000 Service Manual (V1.1)
Warranty
Workmanship & Materials
Mindray guarantees new equipment other than accessories to be free from defects in workmanship and materials for a period of one year (six months for multi-site probes and SpO2 sensor) from date of shipment under normal use and service. Mindray's obligation under this warranty is limited to repairing, at Mindray’s option, any part which upon Mindray's examination proves defective.
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-1000 Patient Monitor if:
assembly operations, extensions, re-adjusts, modifications or repairs are carried out by persons other than those authorized by Mindray.
the MEC-1000 Patient Monitor 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).
MEC-1000 Service Manual (V1.1) 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
Address:
Phone: Fax:
Mindray Building, Keji 12th Road South, Hi-tech Industrial
+86 755 2658 2888 +86 755 2658 2680
EC Representative
Name: Address: Phone: Fax:
Shanghai International Holding Corp. GmbH(Europe) Eiffestrasse 80 D-20537 Hamburg Germany +49 40 2513174 +49 40 255726
Park, Nanshan, Shenzhen, 518057, P. R. China
IV MEC-1000 Service Manual (V1.1)
Preface
This service manual gives a detailed description of the MEC-1000 Patient Monitor, including circuit descriptions, test procedures and a spare part listing. This manual is intended as a guide for technically qualified personnel during repair, testing or calibration procedures.
Following symbols indicates some important facts that you have to pay special attention to:
Warning Points to be noted to avoid injury to the patient and the operator.
Caution Points to be noted to avoid damage to the equipment.
Note Points to be noted.
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Contents
Contents
Chapter 1 General...........................................................................................................1-1
Chapter 2 Principle.........................................................................................................2-1
2.1 MEC-1000 Principle.................................................................................................2-1
2.2 Main control part......................................................................................................2-3
2.3 Parameter Part.........................................................................................................2-4
2.4 Power Board............................................................................................................2-9
2.5 Key Board……………………………………………………………………………….2-11
2.6 Recorder………………………………………………………….……….……….2-12
Chapter 3 Product specification....................................................................................3-1
3.1 Classification............................................................................................................3-1
3.2 Specification.............................................................................................................3-1
Chapter 4 I Structure and Part List ...............................................................................4-1
4.1MEC-1000 Explosive view ........................................................................................4-1
4.1.1 MEC-1000 Explosive view ....................................................................................4-1
4.1.2 MEC-1000 TFT Screen Assembly……………………………………. ....................4-3
4.1.3 MEC-1000 Bracket Assembly...............................................................................4-5
4.1.4 Parameter Socket Assembly .................................................................................4-7
4.1.5 Rear panel Assembly……………………………………. .......................................4-8
4.2 Use of Battery..........................................................................................................4-9
4.3 Part List..................................................................................................................4-9
Chapter 5 Tests...............................................................................................................5-1
5.1 Test Procedure ........................................................................................................5-1
5.2 NIBP Calibrating Method .........................................................................................5-3
5.3 Safety tests……………………………………. .........................................................5-3
Chapter 6 Maintenance and Cleaning...........................................................................6-1
Chapter 7 Troubleshooting............................................................................................7-1
Chapter 8 Maintenance menu........................................................................................8-1
MEC-1000 Service Manual (V1.1) I
General
Chapter 1 General
MEC-1000 is a flexible, portable patient monitor. MEC-1000 can monitor physiological signals including ECG, RESP. Rate, NIBP, SpO physiological signals into digital signals, which can be further processed and used to judge whether to trigger alarm. The user can control the operation of MEC-1000 via using the buttons on the front panel. MEC-1000 can be connected to the central monitoring system via
the Mindray network so as to form a network monitoring system.
MEC-1000 uses ECG electrodes, SpO probe to measure the physiological signals including ECG, NIBP, SpO Rate. In the process of measurement no energy or substances are extracted from and/or delivered to the patient with the exception that sine wave signals are delivered to the patient during measuring RESP Rate. MEC-1000 converts the acquired physiological signals into digital signals, waveform and numerical values and displays all information on the screen. The user can also control the operation of the monitor via using the buttons on the front panel. The user can set alarm limits for each parameter. In this way once finding a physiological parameter exceed the pre-set alarm limits, MEC-1000 will activate its visual and audio alarm (the numerical display flashes or lights on) in order to raise the user’s attention.
, and TEMP. MEC-1000 can convert these
2
finger sensor, blood pressure cuff and temperature
2
, TEMP and RESP
2
1.1 General
During treatment, it is highly important to continuously monitor the vital physiological signs of the patient to transmit the important information. Therefore patient monitor has always been occupying a very important position in the filed of medical devices. The continuous improvement of technologies not only helps us transmit the vital physiological signs to the medical personnel but also simplifies the measurement and as a result raise the monitoring efficiency. For inpatients, we need to measure those vital cardiac and pulmonary signs such as ECG, SpO
, blood pressure and TEMP, etc. In recent years, the technological improvement
2
pertaining to measurement and information transmission has led to more comprehensive performance and stable quality of the patient monitoring products. In the past, the dominant products manufactured by medical device manufacturers are mainly those for single parameter measurement. Nowadays however multi-parameter patient monitors are more widely and commonly used.
1.2 Intended Use
MEC-1000 patient monitor can measure physiological signals including ECG, RESP., NIBP,
and TEMP. It can convert these physiological signals into digital signals and further
SpO
2
display them on the screen. The alarm limits can be user-defined. Once finding a parameter reach or exceed its pre-set alarm limits, MEC-1000 can automatically activate the corresponding alarm. In addition, the user can operate the monitor by using the buttons on the front panel. In addition to outpatient department, monitors are generally used in some clinical areas such as ICU, CCU, operation room and emergency room because the monitor can provide many other physiological parameters of the patient to medical personnel. Only
MEC-1000 Service Manual (V1.1) 1-1
General
the qualified medical personnel shall use MEC-1000 patient monitor.
1.3 Environmental Conditions
1.3.1 Temperature
Operating 0 - 40 °C Transportatio n and Storage -20 - 60 °C
1.3.2 Humidity
Working 15% ~ 95% Transport and Storage 10% ~ 95%(noncondensing)
1.3.3 Altitude
Operating -500 to 4,600 meters Transportation and Storage -500 to 13,100 meters
1.3.4 Electrical specification
100-250 VAC, 50/60Hzmax. input power consumption 110VA
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Principle
Chapter 2 Principle
2.1 MEC-1000 Principle
MEC-1000 portable patient monitor has been designed to measure physiological parameters including ECG, RESP, TEMP, NIBP and SPO2, etc. Figure2-1 shows the structure of the whole monitor as well as the connection relationships between different parts. The board in the center of the figure is the core part of the monitor, i.e., integrated board for main control and parameter measurement, which, though being a single board, could realize the measurements of five said parameters; accordingly uniform AD conversion and digital processing system is used.
Figure 2- 1 MEC-1000 structure and part relationship
In terms of its functionality, MEC-1000 is made up of following parts:
1) Parameter measurement part
2) Main control part
3) Man-machine interface
4) Power supply
5) Other auxiliary part Below is the detailed introduction to each part.
MEC-1000 Service Manual (V1.1) 2-1
Principle
2.1.1 Parameter measurement part
Parameter measurement and monitoring are primary functions of the monitor. The parameter measurement part of the monitor consists of measurement probe (excluded in figure 2-1), parameter input socket assembly, NIBP assembly and the parameter part of the main control board. Its function is to convert the physiological signals into electronic signals, process them and execute calculations according to pre-set programs or the commands from the main control part, and then to send data of values, waveforms and alarms back to the main control part. The data will then be displ ayed via man-ma chine interface.
2.1.2 Main control part
The main control part of the integrated board is to drive man-machine interface, manage parameter measurement and provide other specific functions to the user such as configuration storage, waveform and data recall, etc.
2.1.3 Man-machine interface
The man-machine interfaces are LCD display, recorder, speaker, indicator, keys and knob. The LCD display is the most primary output interface, displaying real-time or history data and
waveforms, various patient information and alarm prompts on the screen for the user’s observation.
Recorder is an auxiliary device to the display, which could print out various user-selected data for use and preservation.
Speaker gives audio alarm. Indicator provides additional information about power supply, battery and alarm. Keys and knob are user input interface of the system, by using which the user could input
information and instructions into the monitor.
2.1.4 Power supply
Power supply is an important part of the system, consisting of power board, backlight board, battery and fan.
The main power board converts the AC mains input into 5V and 12V DC to energize other parts of the system. Similarly LCD display requires particular supply, for which case a backlight board is supplied. The battery could maintain the formal function of the system for a short period when AC mains is disconnected. A small fan requiring DC input is used to realize superior ventilation.
2.1.5 Other auxiliary part
Network port is available on MEC-1000, which allows the service engineer to upgrade the system software without necessarily opening the enclosure of the monitor.And can be
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connected to the Minday Center manage System.
2.2 Main Control Part
2.2.1 Functions of main control part
As the core part of the whole system, it finishes the following functions:
1) control, management and scheduling of parameter measurement part, recorder and
keyboard;
2) display drive of TFT screen, STN screen and CRT screen;
3) 3-way expansion serial port realized by FPGA;
4) alarm given for system fault;
5) storage of RTC, hardware WatchDog and relevant parameters
2.2.2 Schematic Diagram
Principle
UART
RTC
Watchdog
CPU System
RAM/ROM
FPGA
interface
Display
interface
VRAM
Figure 2-2 Schematic Diagram of Main Control Part
2.2.3 Introduction to Principle
The main control Module, being the center part of the system, has serial port s to various modules, TFT display interface, CR T display interface. The BDM interface is reserved on the board for debugging or downloading software.
2.2.3.1 CPU System
CPU is the core element on the main control Module. It connects peripheral modules through BUS and I/Os in order to finish data communication, data processing and logic control, etc.
MEC-1000 Service Manual (V1.1) 2-3
Principle
2.2.3.2 RTC
RTC (real-time clock) provides time (hour, minute, second) and date (year, month, day) information. RTC information can be changed by CPU.
2.2.3.3 FPGA and VRAM
VRAM is used to save display data. CPU sends display data to VRAM via FPGA. The data in VRAM is a map of the real display device. FPGA has various extended serial ports, which communicate with external Parameter Parts. CPU writes acquired data to FPGA, and FPGA sends it to external Parameter Parts.
2.2.3.4 Watchdog
Upon power-up, Watchdog supplies Reset signals to CPU, FPGA and Ethernet Controller.
Provide functions of Waterdog Timer Output and voltage supervise.
2.2.3.5 Ethernet Controller
Ethernet Controller complies with IEEE802.3 / IEEE802.3u LAN standard, supports 10Mbps and 100Mbps data rates, and realizes the data communication between CPU and Ethernet.
2.3 Parameter Part
2.3.1 Introduction to Principle
The parameter part collects, amplifies and filters the signals of the said five physiological parameters, executes A/D over the signals and processes the result signals. Figure 2 -3 shows the structure of this part.
ECG\RESP
Signal
Input\Process
TEMP Signal
Input\Process
SPO2 Signal
Input\Process
NIBP Signal
Input\Process
CPU
System
A/D
Watchdog
Power &
Signal
isolate
Circuit
Figure 2-3 Schematic Diagram of Parameter Part
A/D and CPU in parameter part are shared for processing signals of the said five parameters, i.e., ECG, RESP, TEMP, NIBP and SPO2.
A/D Convert analog signals output from parameter circuit into digital signals, and send them
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into CPU part to receive further processing.
CPU System
Realize logic control over all parameter parts and A/D p art. Process data of each parameter; Communicate with main board.
Power & Signal isolate Circuit
Realize isolation from external circuit in order to ensure human safety; Provide power supplies for circuits; Realize isolating communication between CPU System and main board.
Watchdog
Upon power-on, supply Reset signal to CPU; Provide functions of Watchdog Timer Output and voltage detection.
2.3.2 ECG/RESP Module
Principle
2.3.2.1 General
This module is designed to measure two parameters including ECG, RESP.
2.3.2.2 Schematic Diagram
Figure 2-4 Schematic Diagram of ECG/RESP Module
2.3.2.3 Introduction to Principle
This module uses ECG cables to collect ECG, RESP signals, process them and transmit them to the main control part through serial port.
ECG Signal Input Circuit Input protection and filter circuit: receives ECG signals from cables, removes high-frequency
MEC-1000 Service Manual (V1.1) 2-5
Principle
interference and prevents the circuit from being damaged by high voltage generated in defibrillation and ESD. Right leg drive circuit: picks up 50/60Hz common-mode signals in lead wire and feeds them back to patient body; suppresses the common-mode interference in lead wire for the sake of better detecting ECG signals. Lead Off detection circuit: detects if any ECG lead falls off and transmits relevant message to CPU.
ECG Signal Process Circuit Differential Amplification circuit: first-order amplifies ECG signals and suppresses
common-mode interference at the same time. Low-pass filter circuit: removes high-frequency interference outside frequency band of ECG signals. PACE signals are ECG pacing signals, which greatly affect ECG detecting performance. Therefore PACE suppression circuit is designed to suppress PACE signals in order to better detect ECG signals. Master AMP/Filter circuit: amplifies and filters ECG signals again and transmits them furthermore into A/D converte r.
Pace Detect Pick PACE signals out of ECG signals and transmit them to CPU.
Carrier Generate Circuit RESP measurement is based on Impedance method. Respiration causes the changes of
thoracic impedances, which feature is taken advantage to modulate the amplitude of high frequency carrier. The modulated signals are then sent into the measuring circuit. This circuit is designed to generate high frequency carrier
RESP Signal Input Circuit Couples the RESP signals into the detection circuit.
RESP Signal Process Circuit Preamplifier circuit: amplifies and filters RESP signals;
Detection circuit: picks out the RESP wave modulated in excitation signals; Level translation circuit: removes DC components in RESP signals; Master AMP/Filter circuit: amplifies and filters RESP signals again and transmits them furthermore into A/D converte r.
A/D and CPU System (Description in frame of dashed lines) Refer to the 2.3.1
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Principle
2.3.3 TEMP Module
2.3.3.1 General
This module uses sensors to collect TEMP signals, process them and transmit them to the main control part through serial port.
2.3.3.2 Schematic Diagram
Figure 2-5 Schematic Diagram of TEMP Module
2.3.3.3 Introduction to Principle
Measure temperature of body surface or endocavity by taking advantage of the characteristics of the thermal-sensitive resistor whose impedance varies with temperature of human body.
Temperature Detect Circuit Receive the signal transmitted from TEMP sensor, amplify the signal and send it into A/D
converter.
A/D and CPU System (Description in frame of dashed lines) Refer to the 2.3.1
2.3.4 SPO2 Module
2.3.4.1 General
This module is designed to measure SPO2.
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