Service Manual
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PM-7000 Patient Monitor
Service Manual
© 2006-2010 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved. For this Service Manual, the issued Date is 2010-05 (Version: 7.0).
I
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.
II
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.
III
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.
NOTE z
This equipment must be operated by skilled/trained medical professionals
IV
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.
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 PM-7000 patient monitor if:
Assembly operations, extensions, re-adjusts, modifications or repairs are carried out by persons other than those authorized by Mindray.
Personnel unauthorized by Mindray repairs or modifies the instrument.
V
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
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
VI
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.
WARNING z
Indicates a potential hazard 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.
NOTE z
Provides application tips or other useful information to ensure that you get the most from your product.
2. Meaning of Safety Symbols Symbol
Description Type-BF applied part "Attention"
(Refer to the operation manual.)
VII
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 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.
Do not allow fluids such as water to contact the system or peripheral devices. shock may result.
VIII
Electric
Symbols Equipotential grounding terminal
CE mark 93/42/EEC a directive of the European Economic Community
Be Careful
Protective earth ground
Direct current and alternating current (DC&AC)
Direct current (DC)
Battery indicator
ESD sensitivity
Power ON/OFF
Network connector
High voltage
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.
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FOR YOUR NOTES
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Contents 1 About the Product ... 1-1 1.1 Introduction... 1-1 1.2 Application ... 1-2 1.2.1 General ... 1-2 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 ... 2-3 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... 2-9 2.2.4 SpO2 Module ... 2-10 2.2.5 NIBP Module ... 2-12 2.2.6 Recorder Module... 2-14 2.2.7 Button Panel ... 2-15 2.2.8 Power PCB ... 2-16 2.3 Software Description... 2-18 2.3.1 General ... 2-18 2.3.2 System Task... 2-19 2.3.3 System Function... 2-20 2.4 System Parameter... 2-21 2.4.2 ECG/RESP ... 2-22 2.4.3 NIBP... 2-23 2.4.4 SpO2... 2-24 2.4.5 TEMP ... 2-24 2.4.6 IBP ... 2-25 2.4.7 CO ... 2-25 2.4.8 CO2 ... 2-25 2.4.9 AG ... 2-26 3 Product Specifications ... 3-1 3.1 Safety Classifications ... 3-1 3.2 Environmental Specifications ... 3-1 3.3 Power Source Specifications... 3-2 1
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... 3-10 3.10 SpO2 Specifications...3-11 3.11 NIBP Specifications ... 3-13 3.12 TEMP Specifications... 3-14 3.13 IBP Specifications ... 3-14 3.14 CO Specifications... 3-15 3.15 CO2 Specifications ... 3-16 3.16 AG Specifications... 3-18 4 Disassembling/Assembling & Troubleshooting... 4-1 4.1 PM-7000 Disassembling/Assembling ... 4-1 4.1.1 Exploded View of PM-7000... 4-1 4.1.2 PM-7000 Support Assembly ... 4-2 4.1.3 Front Bezel Assembly ... 4-5 4.1.4 Rear Housing Assembly ... 4-6 4.1.5 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 ... 5-2 5.1.4 . Recommended Frequency ... 5-2 5.2 Preventative Maintenance Procedures ... 5-4 5.2.1 Visual Inspection ... 5-4 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... 5-12 5.3 Power On Test ... 5-14 5.4 Module Performance Tests... 5-14 5.4.1 ECG Tests... 5-14 2
5.4.2 Resp Performance Test... 5-15 5.4.3 SpO2 Test... 5-16 5.4.4 NIBP Tests... 5-16 5.4.5 Temp Test ... 5-17 5.4.6 IBP Tests... 5-17 5.4.7 C.O. Test... 5-18 5.4.8 Sidestream and Microstream CO2 Module Tests... 5-19 5.4.9 AG Tests ... 5-19 5.5 Nurse Call Relay Performance Test ... 5-19 5.6 Analog Output Performance Test ... 5-20 5.7 Electrical Safety Test... 5-20 5.8 Recorder Check... 5-20 5.9 Battery Check... 5-21 5.10 Bill of Materials for PM-7000 Main Unit ... 5-26 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 A Electrical Safety Inspection ... A-1 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-13
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FOR YOUR NOTES
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1 About the Product 1.1 Introduction The PM-7000 Patient Monitor (hereinafter called PM-7000 for short), 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-7000 can be connected with the central monitoring system whereby a monitoring network will be formed. Parameters that the PM-7000 can monitor include: ECG, RESP, SpO2, NIBP, 2-channel TEMP, 2-channel IBP, CO, CO2 and AG. 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 7 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-7000 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.
1-1
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.
1.2.2 Usage Parameters that the PM-7000 include: ECG, RESP, SpO2, NIBP, TEMP, IBP, CO AG and CO2. PM-7000 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-7000 should be run under the control of clinical staff. PM-7000 has the following functions: ECG
RESP SpO2 NIBP TEMP IBP
CO CO2
Heart Rate (HR) 2-channel ECG waveform Arrhythmia analysis and S-T analysis (optional) Respiration Rate (RR) Respiration waveform Pulse Oxygen Saturation(SpO2), Pulse Rate (PR) SpO2 Plethysmogram Systolic pressure (NS), diastolic pressure (ND), mean pressure (NM) T1, T2, TD CH1: SYS, DIA CH2: SYS, DIA IBP waveform Temperature of blood (TB) Cardiac Output (CO) End-tidal carbon dioxide (EtCO2) 1-2
AG
Inspired minimum CO2 (InsCO2) Airway Respiration Rate (AwRR) 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-7000 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
FOR YOUR NOTES
1-4
2 Principles 2.1 General The intended use of the PM-7000 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-7000 2-1