Service Manual
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PM-8000 Express
Patient Monitor
Service Manual
Copyright
© 2005-2006 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved. For this Service Manual, the issued Date is 2006-11 (Version: 1.1).
Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information 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. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rent, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. ,
,
,
,
trademarks owned by Mindray in China and other countries.
are the registered trademarks or All other trademarks that appear in this
manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.
Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice. All information contained in this manual 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 manual. Mindray is responsible for safety, reliability and performance of this product only in the condition that:
• all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;
• the electrical installation of the relevant room complies with the applicable national and local requirements;
• the product is used in accordance with the instructions for use. I
Service Manual
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.
Note This equipment must be operated by skilled/trained medical professionals.
Warning 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. z
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.
z
This multi-parameter patient monitor is intended for use only by medical professionals in health care institutions.
z
To avoid electrical shock, you shall not open any cover by yourself. Service must be carried out by qualified personnel.
z
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.
z
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.
Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
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Service Manual
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 use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to: z
any Mindray product which has been subjected to misuse, negligence or accident;
z
any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed;
z
any product of any other manufacturer.
Safety, Reliability and Performance Mindray is not responsible for the effects on safety, reliability and performance of the PM 910Vet patient monitor if: z
Assembly operations, extensions, re-adjusts, modifications or repairs are carried out by persons other than those authorized by Mindray.
z
Personnel unauthorized by Mindray repairs or modifies the instrument.
Return Policy Return Procedure In the event that it becomes necessary to return this product or part of this product 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. Returned 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 this product is shipped to Mindray for service (this includes customs charges).
3.
Return address: Please send the part(s) or equipment to the address offered by Customer Service department
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Service Manual
Company Contact Manufacturer:
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address:
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057 P.R. China
Tel:
+86 755 26582479
+86 755 26582888
Fax:
+86 755 26582500
+86 755 26582501
Website:
www.mindray.com.cn
EC-Representative:
Shanghai International Holding Corp. GmbH (Europe)
Address:
Eiffestraße 80, 20537 Hamburg Germany
Tel:
0049-40-2513175
Fax:
0049-40-255726
IV
Service Manual
Safety Precautions 1.
Meaning of Signal Words
In this service manual, the signal words
DANGER,
WARNING,
CAUTION and NOTE
are used to indicate safety and other important instructions The signal words and their meanings are defined as follows. Signal word
Meaning Indicates an imminently hazardous situation which, if not avoided, will
DANGER
result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, could
WARNING
result in death or serious injury. Indicates a potentially hazardous situation which, if not avoided, may
CAUTION
result in minor or moderate injury. Indicates a potentially hazardous situation which, if not avoided, may
NOTE 2.
result in property damage.
Meaning of Safety Symbols
Symbol
Description Type-BF applied part "Attention" (Refer to the operation manual.)
3.
Safety Precautions
Please observe the following precautions to ensure patient and operator safety when using this system.
DANGER:Do not use flammable gasses such as anesthetics, or flammable liquids such as ethanol, near this product, because there is danger of explosion.
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 overcurrent, or when there is an instantaneous current at power ON, the circuit breakers and fuses of the building’s supply circuit may be tripped.
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Service Manual
CAUTION:
1.
Malfunctions due to radio waves
(1) Use of radio-wave-emitting devices near the monitor 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. (2) 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. 2.
Do not allow fluids such as water to contact the system or peripheral devices.
Electric shock may result.
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Service Manual
Symbols
See instructions
Protective earth ground
Indicates that the instrument is IEC-60601-1 Type CF equipment. The unit displaying this symbol contains an F-Type isolated (floating) patient applied part providing a high degree of protection against shock, and is suitable for use during defibrillation.
Equipotential grounding terminal
CE mark 93/42/EEC a directive of the European Economic Community
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Service Manual
Contents Warranty...II Return Policy ... III Safety Precautions ... V Chapter 1 About the Product ...1-1 1.1
Introduction ...1-1
1.2
Application...1-1
1.3
Environment...1-2
Chapter 2 Principles...2-1 2.1
General ...2-1
2.2
Hardware Description ...2-2
2.3
Software Description ...2-14
2.4
System Parameter ...2-16
Chapter 3 Product Specifications...3-1 3.1
Safety Designations ...3-1
3.2
Environmental Characteristics...3-1
3.3
Power Requirements ...3-1
3.4
Hardware Specifications...3-2
3.5
Outputs ...3-3
3.6
ECG Specifications ...3-4
3.7
RESP Specifications ...3-6
3.8
SpO2 Specifications...3-7
3.9
NIBP Specifications...3-8
3.10
TEMP Specifications...3-8
3.11
IBP Specifications...3-9
3.12
CO2 Specifications ...3-9
Chapter 4 Disassembling/Assembling & Troubleshooting...4-1 4.1
PM-8000 Express Disassembling/Assembling ...4-1
4.2
Troubleshooting...4-8
Chapter 5 Test and Material List ...5-1 5.1
Test Procedure ...5-1
5.2
NIBP Calibration ...5-5
5.3
IBP CALIBRATE ...5-5
5.4
PM-8000 Express Material List ...5-8
Chapter 6 Maintenance and Cleaning ...6-1 6.1
Maintenance ...6-1 I
Service Manual
6.2
Cleaning...6-1
6.3
Cleaning Reagent ...6-1
6.4
Disinfection...6-2
II
About the Product
Chapter 1 1.1
About the Product
Introduction
The PM-8000 Express Patient Monitor, a portable and accessible patient monitor, which applies to adults, pediatric and neonates, is supplied by rechargeable battery or external AC and DC power. You can select different configurations as required. Besides, the PM-8000 Express can be connected with the central monitoring system whereby a monitoring network will be formed. Parameters that the PM-8000 Express can monitor include: ECG, RESP, SpO2, NIBP, 2-channel TEMP, 2-channel IBP, and CO2. It is a compact and lightweight patient monitor. Its color TFT LCD is able to show patient parameters and 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 PM-8000 Express Patient Monitor measures patient’s ECG, NIBP, SpO2, TEMP, RESP, IBP, 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.
1.2 Application 1.2.1
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, 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.
1.2.2
Usage
PM-8000 Express converts 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. The PM-8000 Express patient monitor should be run under the control of clinical staff. PM-8000 Express patient monitor has the following functions: 1-1
About the Product
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
CO2
End-tidal carbon dioxide (EtCO2) Inspired minimum CO2 (InsCO2) Airway Respiration Rate (AwRR)
The PM-8000 Express 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.
1.3 Environment 1.3.1
Temperature
Work mode Transportation & Storage 1.3.2
0 – 40℃ -20 – 60℃
Humidity
Work mode
15% – 95 % (non-condensing)
Transportation & Storage
10% – 95 % (non-condensing)
Atmospheric pressure
70.0kPa – 106.0kPa
1.3.3
Electrical specification
100 – 240 V AC, 50/60 Hz, Maximum input power: 110VA; 10 – 16V DC (12V rating), Maximum input power: 70W;
1-2
Principles
Chapter 2
Principles
2.1 General The intended use of the PM-8000 Express patient monitor is to monitor a fixed set of parameters including ECG, RESP, SpO2, NIBP, TEMP, IBP, and CO2 (IBP 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 PM-8000 Express
2.1.1
Parameter Measurement
The parameter measurement and monitoring are the core functions of the patient monitor. The 2-1
Principles
parameter measurement part of the PM-8000 Express 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 electrical signals, processes 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.
2.1.2
Main Control Part
In the PM-8000 Express 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)
2.1.3
Man-Machine Interface
The man-machine interface of the PM-8000 Express 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.
2.1.4
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 and DC 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.
2.1.5
Other Auxiliary Functions
The PM-8000 Express patient monitor also provides the network upgrade function for the service engineers to upgrade the system software without disassembling the enclosure.
2.2
Hardware Description
The structure of the PM-8000 Express patient monitor is shown in the following figure.
2-2
Principles
Figure 2-2 Functional structure of the PM-8000 Express
2-3
Principles
The PM-8000 Express 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.
2.2.1
Main Board
2.2.1.1 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.
2-4
Principles
2.2.1.2 Principle diagram
Figure 2-4 Working principle of the main board
2.2.1.3 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. 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. 2-5
Principles
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. 2.2.2
ECG/RESP/TEMP Module
2.2.2.1 General This module provides the function of measuring three parameters: electrocardiograph (ECG), respiration (RESP) and temperature (TEMP).
2.2.2.2 Principle diagram
Figure 2-5 Working principle of the ECG/RESP/TEMP module
2.2.2.3 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. The PACE signal refers to the ECG pace signal. It has significant interference to the ECG signal 2-6
Principles
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. 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.
2-7
Principles
2.2.3
IBP Module
2.2.3.1 General This module provides the function of measuring Invasive Blood Pressure (IBP).
2.2.3.2 Principle diagram
Figure 2-6 Working principle of the IBP module
2.2.3.3 Principle This module collects the IBP signal through the transducers, processes it and sends it to the main board throgh the serial port.
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; Implementing the communication with the CPU board. 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.
2.2.4
SpO2 Module
2.2.4.1 General This module provides the function of measuring the Pulse Oxygen Saturation (SPO2).
2-8