PM-9000 Express Service Manual Ver 5.0 May 2010

© 2005-2010 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved. For this Service Manual, the issued Date is 2010-05 (Version: 5.0).

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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. . , and are the registered trademarks or trademarks owned by Mindray in China and other countries. 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.

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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.

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.

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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

z z z

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. 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.

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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 use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel. This warranty shall not extend to: „ any Mindray product which has been subjected to misuse, negligence or accident; „ any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed; „ any product of any other manufacturer.

Safety, Reliability and Performance Mindray is not responsible for the effects on safety, reliability and performance of the PM9000 Express Patient Monitor if: „ „

assembly operations, extensions, re-adjusts, modifications or repairs are carried out by persons other than those authorized by Mindray. the PM-9000 Express 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).

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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).

3.

Return address: Please send the part(s) or equipment to the address offered by Customer Service department

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 26522479

+86 755 26582888

Fax:

+86 755 26582934

+86 755 26582500

Website:

www.mindray.com

EC-Representative:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestraße 80, 20537 Hamburg Germany

Tel:

0049-40-2513175

Fax:

0049-40-255726

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Safety Precautions 1. Meaning of Signal Words In this manual, the signal words DANGER, WARNING, and CAUTION are used regarding safety and other important instructions. The signal words and their meanings are defined as follows. Please understand their meanings clearly before reading this manual.

DANGER z

Indicates an imminent hazard situation that, if not avoided, will result in death or serious injury.

WARNING z

Indicates a potential hazard situation or unsafe practice that, if not avoided, could result in death or serious injury.

CAUTION z

Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

2. Meaning of Safety Symbols Symbol

Description Type-BF applied part "Attention" (Refer to the operation manual.)

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3. Safety Precautions Please observe the following precautions to ensure the safety of service engineers as well as operators when using this system.

DANGER z

Do not use flammable gases such as anesthetics, or flammable liquids such as ethanol, near this product, because there is danger of explosion.

WARNING z

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.

CAUTION 1.Malfunctions due to radio waves z 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. z 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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Contents 1 About the Product ... 1-1 1.1 Introduction... 1-1 1.2 Application ... 1-1 1.2.1 General ... 1-1 1.2.2 Usage... 1-2 2 Principles... 2-1 2.1 General ... 2-1 2.1.1 Parameter Measurement... 2-2 2.1.2 Main Control Part... 2-2 2.1.3 Man-Machine Interface ... 2-2 2.1.4 Power Supply ... 2-2 2.1.5 Other Auxiliary Functions... 2-3 2.2 Hardware Description ... 2-3 2.2.1 Main Board... 2-4 2.2.2 ECG/RESP/TEMP Module ... 2-6 2.2.3 CO/IBP Module... 2-8 2.2.4 SpO2 Module... 2-9 2.2.5 NIBP Module ... 2-10 2.2.6 Recorder Module... 2-12 2.2.7 Button Panel ... 2-13 2.2.8 Power PCB ... 2-14 2.3 Software Description... 2-15 2.3.1 General ... 2-15 2.3.2 System Task... 2-16 2.3.3 System Function... 2-17 2.4 System Parameter... 2-18 2.4.1 General ... 2-18 2.4.2 ECG/RESP ... 2-19 2.4.3 NIBP... 2-20 2.4.4 SpO2... 2-20 2.4.5 TEMP ... 2-21 2.4.6 IBP ... 2-21 2.4.7 CO ... 2-21 2.4.8 CO2 ... 2-22 2.4.9 AG ... 2-22 3 Product Specifications ... 3-1 3.1 Safety Classifications ... 3-1 3.2 Environmental Specifications ... 3-1 3.3 Power Source Specifications... 3-2 3.4 Hardware Specifications ... 3-3 3.5 Wireless network... 3-4 3.6 Data Storage ... 3-4 3.7 Signal Output Specifications... 3-4 3.8 ECG Specifications ... 3-5 3.9 RESP Specifications... 3-9 3.10 SpO2 Specifications... 3-10 3.11 NIBP Specifications ...3-11 3.12 TEMP Specifications... 3-12 3.13 IBP Specifications ... 3-12 3.14 CO Specifications... 3-13

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3.15 CO2 Specifications ... 3-13 3.16 AG Specifications... 3-15 4 Disassembling/Assembling & Troubleshooting... 4-1 4.1 PM-9000 Express Disassembling/Assembling ... 4-1 4.1.1 Exploded View of PM-9000 Express ... 4-1 4.1.2 PM-9000 Express Display (TFT Display) Assembly ... 4-2 4.1.3 PM-9000 Express Support Assembly (Lithium Battery) (9201-30-35944) ... 4-3 4.1.4 Front Cover Assembly... 4-4 4.1.5 Back Cover Assembly ... 4-5 4.1.6 Microstream CO2 Assembly ... 4-7 4.2 Troubleshooting ... 4-8 4.2.1 Black Screen, Startup Failure... 4-8 4.2.2 White Screen & Other Abnormal Screen ... 4-9 4.2.3 Encoder Faults... 4-9 4.2.4 No Audio Alarm ... 4-9 4.2.5 Printing Failure... 4-9 4.2.6 Abnormal Paper Drive... 4-9 5 Test and Material List... 5-1 5.1 Introduction... 5-1 5.1.1 Test Equipment... 5-1 5.1.2 Test Report ... 5-1 5.1.3 Preventative Maintenance ... 5-1 5.1.4 . Recommended Frequency ... 5-2 5.2 Preventative Maintenance Procedures ... 5-3 5.2.1 Visual Inspection ... 5-3 5.2.2 NIBP Tests... 5-4 5.2.3 Sidestream and Microstream CO2 Module Tests... 5-7 5.2.4 AG Tests ... 5-9 5.2.5 Preventative maintenance test report...5-11 5.3 Power On Test ... 5-12 5.4 Module Performance Tests... 5-12 5.4.1 ECG Tests... 5-12 5.4.2 Resp Performance Test... 5-13 5.4.3 SpO2 Test... 5-13 5.4.4 NIBP Tests... 5-13 5.4.5 Temp Test ... 5-14 5.4.6 IBP Tests... 5-14 5.4.7 C.O. Test... 5-15 5.4.8 Sidestream and Microstream CO2 Module Tests... 5-15 5.4.9 AG Tests ... 5-15 5.5 Nurse Call Relay Performance Test ... 5-16 5.6 Analog Output Performance Test ... 5-16 5.7 Electrical Safety Test... 5-16 5.8 Recorder Check... 5-17 5.9 Battery Check... 5-17 5.10 PM-9000 Express Material List ... 5-21 6 Maintenance and Cleaning... 6-1 6.1 Maintenance ... 6-1 6.1.1 Checking Before Using ... 6-1 6.1.2 Regular Checking... 6-1 6.2 Cleaning ... 6-1 6.3 Cleaning Reagent ... 6-2 6.4 Sterilization ... 6-2 6.5 Disinfection... 6-2

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A.1 Power Cord Plug ... A-2 A.2 Device Enclosure and Accessories... A-2 A.3 Device Labeling ... A-3 A.4 Protective Earth Resistance... A-3 A.5 Earth Leakage Test... A-5 A.6 Patient Leakage Current ... A-6 A.7 Mains on Applied Part Leakage... A-9 A.8 Patient Auxiliary Current...A-11 A.9 Functional test ... A-12

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FOR YOUR NOTES

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1 About the Product 1.1 Introduction The PM-9000 Express 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 PM-9000 Express can be connected with the central monitoring system whereby a monitoring network will be formed. Parameters that the PM-9000 Express 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 PM-9000 Express 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.

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, 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.

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1.2.2 Usage Parameters that the PM-9000 Express can monitor include: ECG, RESP, SpO2, NIBP, TEMP, IBP, CO AGand CO2. PM-9000 Express 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 PM-9000 Express patient monitor should be run under the control of clinical staff. PM-9000 Express 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 TEMP

Systolic pressure (NS), diastolic pressure (ND), mean pressure (NM) 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)

AG

Inhaled and exhaled CO2 (FiCO2, EtCO2) Inhaled and exhaled N2O (FiN2O, EtN2O) Inhaled and exhaled O2 (FiO2, EtO2) Inhaled and exhaled anesthetic agent (FiAA, EtAA, where AA refers to any of the following anesthetic agents.) HAL (Halothane) ISO (Isoflurane) ENF (Enflurane) SEV (Sevoflurane) DES (desflurane) Airway Respiration Rate (rpm: Respiration Per Minute): AwRR Minimum Alveolar Concentration (MAC) 4 AG waveforms (CO2, N2O, O2, AA)

The PM-9000 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.

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2 Principles 2.1 General The intended use of the PM-9000 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 PM-9000 Express

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2.1.1 Parameter Measurement The parameter measurement and monitoring are the core functions of the patient monitor. The parameter measurement part of the PM-9000 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 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.

2.1.2 Main Control Part In the PM-9000 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-9000 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 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.

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2.1.5 Other Auxiliary Functions The PM-9000 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-9000 Express patient monitor is shown in the following figure.

Figure 2-2 Functional structure of the PM-9000 Express

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The PM-9000 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.

2.2.1.2 Principle diagram

Figure 2-4 Working principle of the main board

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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. 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.

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